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SURGICAL TECHNIQUE SUBCONDYLAR RAMUS FIXATION SET Instruments and implants approved by the AO Foundation. This publication is not intended for distribution in the USA.

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Page 1: SUBCONDYLAR RAMUS FIXATION SET - synthes.vo.llnwd.net

SURGICAL TECHNIQUE

SUBCONDYLAR RAMUS FIXATION SET

Instruments and implants approved by the AO Foundation.This publication is not intended for distribution in the USA.

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Image intensifier control

This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is recommended.

WarningsThese devices can break during use (when subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed.

Medical devices containing stainless steel may elicit an allergic reaction in patients with hypersensitivity to nickel.

Processing/reprocessing of the deviceDetailed instructions for processing implants and reprocessing reusable devices, instrument trays and cases are described in the DePuy Synthes brochure “Important Information”. Assembly and disassembly instructions of instruments “Dismantling multipart instruments” can be downloaded fromhttp://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 1

INTRODUCTION Intended Use and Indications 2

AO Principles, General Adverse Events 3

Instruments in the Subcondylar 5 Ramus Fixation Set

SURGICAL TECHNIQUE Intraoral Less Invasive Approach – 9 Subcondylar Fracture Repair

Fracture Exposure and Creation of Optical Cavity 11

Fracture Reduction 16

Fracture Fixation 19

Submandibular Less Invasive Approach – 29 Subcondylar Fracture Repair

Preparation 29

Exposure and Creation of the Optical Cavity 31

Fracture Reduction 38

Fracture Fixation 43

PRODUCT INFORMATION Subcondylar Ramus Fixation Set 53

Suggested Reading List 54

TABLE OF CONTENTS

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2 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

INTENDED USE AND INDICATIONS

INTENDED USE

INDICATIONS

The Subcondylar Ramus Fixation Set [115.680] includes specialized instrumentation designed to support the en-doscopic treatment of trauma and orthognathic surgery involving the subcondylar ramus region of the mandible. The Subcondylar Ramus Fixation Set is intended for endoscopic intraoral and sub mandibular approaches to subcondylar fractures only.

Subcondylar Fracture Management• Endoscopic or open treatment of a noncomminuted

subcondylar fracture of the mandible with plate and screw fixation in which a minimum of two screws can be placed through a plate into the proximal fracture fragment.

• Reduction of dislocated fracture fragment.

Orthognathic Surgery• Endoscopic or open orthognathic procedures involving

the ramus and condylar region of the mandible such as:• vertical ramus osteotomy with rigid fixation• condylectomy• condylotomy

Credit: Maria Troulis, BSc, DDS, MSc

Credit: Maria Troulis, BSc, DDS, MSc

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 3

Anatomic ReductionSpecialized instrumentation assists in the exposure and reduction of the fracture or osteotomy.

AO PRINCIPLES

AO PRINCIPLES, GENERAL ADVERSE EVENTS

Stable Internal FixationPlate and screws provide stability for both the subcondy-lar fracture and ramus osteotomy.

Atraumatic Surgical TechniqueEndoscopic approach reduces required dissection. Less disturbance of the soft tissue promotes rapid healing and return to function.

Early, Active, Pain-Free MobilizationStable fixation eliminates traditional, long-term maxillo-mandibular fixation (MMF) permitting an early return to function.

Credit: Ralf Schön, MD, DDS

Credit: Reid Mueller, MD

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4 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

GENERAL ADVERSE EVENTSAs with all major surgical procedures, risks, side effects and adverse events can occur. While many possible reac-tions may occur, some of the most common include:Problems resulting from anesthesia and patient position-ing (e.g. nausea, vomiting, neurological impairments, etc.), thrombosis, embolism, infection or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues incl. swelling, abnormal scar formation, functional impairment of the musculo-skeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hyperreac-tions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the implant, reoperation.

Device Specific Adverse EventsDevice specific adverse events include but are not limited to: Screw Loosening/pull out, Plate breakage, Explanta-tion, Pain, Seroma, Hematoma, Infection.

AO Principles, General Adverse Events

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 5

U44-48220 Retractor, curved, double-ended, length 200 mm, size 1, for soft tissue dissection and fracture reduction

386.906 Freer Suction Elevator, with Cleaning Stylet B 1.8 mm

For soft tissue dissection and removal of fluid for improved visualization.

386.915 Handle for Optical Retractor

Retracts soft tissue to provide optical cavity while securing endoscope in de-sired position. Use with interchangeable retractor blades.

386.917 Insert for Optical Retractor, width 12 mm

386.918 Insert for Optical Retractor, width 17 mm Used with Optical Retractor Handle for retraction of soft tissue and maintaining optical cavity. Opening in 17 mm blade allows passage of 2.0 mm Cannula and Obturator.

321.170 Pin Wrench B 4.5 mm, length 120 mm

398.415 Retractor, straight, double-ended, length 240 mm, for soft tissue dissection

INSTRUMENTS IN THE SUBCONDYLAR RAMUS FIXATION SET

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1 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

397.211 Universal Handle for Drill Sleeves

Aids insertion and positioning of 2.0 mm Cannula and Obturator.

386.908 Cheek Retractor Ring with thread,for No. 386.914

Optional instrument for retraction of soft tissue. Used with the 2.0 mm threaded cannula.

386.912 Reduction Forceps for Fragments, with Points, narrow, ratchet lock, length 210 mm

Reduces fracture fragments. Aids assembly of Cheek Retractor Ring to 2.0 mm threaded cannula.

386.910 Subcondylar Elevator, right angled386.911 Subcondylar Elevator, left angled

Supports and manipulates fracture fragments to achieve fracture reduction.

386.914 Drill Sleeve 2.0 with Trocar, with thread, length 72 mm

Provides portal for drilling and placing screws. Accepts threaded cheek retractor ring for retraction of soft tissue.

Instruments in the Subcondylar Ramus Fixation Set

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 7

386.902 Manipulation Screw B 1.9 mm, self-drilling, length 80 mm

Aids fracture reduction and temporary plate fixation.

311.013 Handle, large, with mini quick coupling

Used for inserting the Manipulation Screw B 1.9 mm, self-drilling, length 80 mm and with screwdriver blades.

386.903 Handle for Manipulation Screw No. 386.902

Used with the Manipulation Screw B 1.9 mm, self-drilling, length 80 mm to aid in fracture reduction.

386.901 Tip for Plate Holder No. 386.900

386.900 Plate Holder, adjustable, complete

Aids in plate insertion and alignment.

386.904 Drill Sleeve 2.0 with Trocar, self-holding, length 62 mm

Provides portal for drilling and placing screws.

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8 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

316.520 Drill Bit B 1.5 mm, length 125 mm, 2-flute, for J-Latch Coupling

Creates hole for insertion of 2.0 mm screws.

386.913 Drill Sleeve 1.5, length 67 mm

Provides portal for predrilling for screws.

386.905 Hook, blunt, angled, B 1.5 mm

Assists in plate positioning and fracture reduction.

386.920 Retractor, length 60 mm, width 8 mm

Assists with retraction of soft tissue when creating a limited temporary optical cavity.

347.980 Holding Forceps for Plates

Assists with handling of plates and screws.

314.442 Screwdriver Shaft 1.5/2.0, cruciform, self-holding, length 92 mm

For screw insertion and to secure the plate to the Plate Holding Tip of the Articulating Plate Introducer.

Instruments in the Subcondylar Ramus Fixation Set

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Fracture

AssistantSurgeon

X

Monitor

Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 9

1 Identify and mark landmarks

Prior to patient intubation, identify and mark the follow-ing relevant anatomic landmarks of the mandible and outline the fracture site or planned osteotomy:• Midline• Inferior border• Sigmoid notch• Angle• Posterior border• Temporomandibular joint• Zygomatic arch• Anterior border• Superior border of the body

INTRAORAL LESS INVASIVE APPROACH – SUBCONDYLAR FRACTURE REPAIR

PREPARATION

2 Position video monitor for endoscope

The top and both sides of the patient’s head must be ac-cessible to the surgeon and assistant. Position the video monitor for the endoscope at the head of the operating table towards the patient’s contralateral shoulder. The surgeon should stand on the ipsilateral side and the as-sistant on the contralateral side of the incision site.

Credit: Reid Mueller, MD

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11 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

3 Place patient in MMF

Place the patient in temporary MMF with elastic traction

Precaution: Address other fractures, if present, prior to subcondylar fracture fixation.

Intraoral Less Invasive Approach – Subcondylar Fracture Repair

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 11

Intraoral

FRACTURE EXPOSURE AND CREATION OF OPTICAL CAVITY

1 Expose fracture

Expose the fracture through a 2 cm intraoral incision, along the anterior border of the ascending ramus, carried down to the periosteum.

2 Create optical cavity

Create an optical cavity for visualization by elevating the soft tissue in a subperiosteal plane from the entire lateral ramus of the mandible and the posterior border. Using the Retractor, straight, double-ended, length 240 mm [398.415] or Retractor, curved, double-ended, length 200 mm, size 1 [U44-48220] create a wide subperiosteal dissection to provide a large optical cavity for improved visualization.

Credit: Reid Mueller, MD

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12 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

3 Insert endoscope

Retract the soft tissue and insert the endoscope, with matching irrigating sheath, into the optical cavity. Lighted telescopes, of 2.7 mm through 4.0 mm diameter and with 30° or 45° angles, are commonly used for this application.

4 Carry dissection proximally

Carry the periosteal dissection proximally using the double-ended elevators or the Freer Suction Elevator [386.906] to maximize visualization and access. Continue dissection along the posterior border and over the lateral surface of the proximal fragment after it is identified.

Note: Fit a suction tube onto the back end of the Freer Suction Elevator and activate suction by plac-ing a finger over the port.

IntraoralFracture Exposure and Creation of Optical Cavity

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386.915

386.918

5A

5C

5B

5D

Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 13

5 Assemble the optical retractor

Insert the endoscope with sheath into the assembled optical retractor.

Note: The optical retractor assembly consists of two parts, the Handle for Optical Retractor [386.915] which accepts a lighted endoscope with sheath (2.7 mm –4.0 mm), and a Insert for Optical Retractor, available in two widths, 12 mm [386.917] and 17 mm [386.918]. The 17 mm blade is typically used for the intraoral approach.

To assemble the retractor, first place the appropriate Retractor Blade into the coupling nut on the Optical Re-tractor Handle and secure by finger tightening the nut (Fig. 5A). Then insert the endoscope with sheath into the securing clamp on the Optical Retractor Handle (Fig. 5B). Position the endoscope so that the preferred view is obtained. Secure by turning the knob (Fig. 5C). Attach the optional handle extension to the Optical Re-tractor Handle for alternate holding positions (Fig. 5D).

Precaution: To prevent damage to the endoscope, the appropriate sheath must be used.

Handle extension can be inserted on either side of the handle.

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14 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

6 Place optical retractor assembly

Insert the optical retractor assembly with endoscope into the optical cavity and place the hooked tip around the posterior border. Complete dissection of the proximal fragment as neces-sary for plate placement. Support of the retractor and endoscope can be transferred to an assistant.

Precaution: Sufficient periosteum must be elevated from the posterior border of the ramus to allow placement of the optical retractor.

IntraoralFracture Exposure and Creation of Optical Cavity

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 15

Optional Technique:The Cheek Retractor Ring with thread, for No. 386.914 [386.908] when assembled to the Drill Sleeve 2.0 with Trocar [386.914] may be used as an alternative to the optical retractor assembly. The cannula will also provide a transbuccal portal for drilling and passage of 2.0 mm screws. Insert Drill Sleeve 2.0 with Trocar [386.914] into the Universal Handle for Drill Sleeves [397.211]. Make a cutaneous puncture for the trocar placement at a point perpendicular to, and directly over, the sub-condylar fracture line. A curved clamp may be inserted into the intraoral incision and the cheek pushed out over the fracture to identify the correct placement of the tro-car stab incision.

Precaution: The patient should not be paralyzed during insertion of the trocar so stimulation to the facial nerve can be identified and the trocar redirected if necessary. Initial spreading dissection with a clamp prior to trocar insertion is helpful.

Insert the cannula and obturator through the stab inci-sion and press down to the bone.

Thread the Cheek Retractor Ring [386.908] onto the Drill Sleeve 2.0 with Trocar [386.914] using the Reduction Forceps for Fragments [386.912]. Rotate the cannula head clockwise to engage the ring on the threads of the cannula.

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386.912

11 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

Fracture reduction is often the most challenging part of the surgical procedure. Musculoskeletal forces typically drive the ramus superiorly resulting in proximal fragment override. Distracting the mandible inferiorly can signifi-cantly aid in reduction. Transverse fractures so reduced may provide sufficient interfragmentary friction to main-tain reduction during plating.

Intraoral

FRACTURE REDUCTION

1 Distract the mandible

Distract the mandible if necessary. This may be accom-plished by placing the straight elevator between the patient’s molars and rotating it. Distraction may also be achieved by using the Reduction Forceps for Fragments [386.912] to grasp the angle and distract as needed. Release MMF elastics if necessary but reapply after re-duction.

Straight Elevator

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 17

2 Reduce the fracture

Option 1Reduce the laterally displaced proximal fragment by ma-nipulating it medially. Use the obturator tip, Freer eleva-tors or Fragment Manipulating Forceps to aid reduction.

Option 2Use the Subcondylar Elevator, right angled [386.910] or left angled [386.911] to laterally reduce a medially dis-placed fragment.

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18 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

Option 3

Reduction can also be achieved using the Manipulation Screw B 1.9 mm [386.902] and Handle for Manipulation Screw No. 386.902 [386.903].

First insert the Drill Sleeve 2.0 with Trocar, self-holding [386.904] through a trocar incision at a suitable location, superior to the fracture line, where the top plate hole will be located. Remove the obturator and insert the Manipulation Screw B 1.9 mm through this 2.0 mm can-nula.

Precaution: The patient should not be paralyzed during insertion of the trocar so stimulation to the facial nerve can be identified and the trocar redirected if necessary. Initial spreading dissection with a clamp prior to trocar insertion is helpful.

The Manipulation Screw B 1.9 mm is self-drilling and must be fully inserted into the proximal fragment using the Handle, large, with mini quick coupling [311.013].

Precaution: This device should be used only in healthy bone, in an area with adequate bone stock to prevent splitting the bony margins.

Prior to manipulation of the bone, replace the screw-driver handle with the lightweight Fragment Manipulator Handle for manipulation and reduction of the proximal fragment.

Precaution: If the screwdriver handle is not replaced, loss of reduction and bending of the Manipulation Screw B 1.9 mm may occur.

Gently manipulate the fracture fragment until reduction is achieved.

Note: See Step 3, page 22, for use of the Manipula-tion Screw B 1.9 mm in conjunction with a plate.

IntraoralFracture Reduction

Manipulation Screw B 1.9mm, self-drilling, length 80 mm (386.902)

Use 311.013 Handle, large, with mini quick coupling for insertion of 386.902

Use 386.903 handle for manipulation of fragment with 386.902

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 19

Intraoral

FRACTURE FIXATION

Stable fracture fixation may be achieved using a 2.0 mm Dynamic Compression Plate affixed with a minimum of two screws, but preferably three screws, on either side of the fracture.

1 Load plate onto Articulating Plate Introducer

Load the desired 2.0 mm plate onto the flexible Plate Holding Tip of the Articulating Plate Introducer [386.900] by first ensuring that the “U” (unlocked posi-tion) on the retention fastener is aligned with the arrow on the Plate Holding Tip. The Screwdriver Shaft 1.5/2.0, cruciform, self-holding [314.442] and Handle, large, with mini quick coupling [311.013], may be used to achieve alignment if necessary.

Turn the Plate Holding Tip so the cruciform retention fastener faces downward. Turn the selected Dynamic Compression Plate over to view the underside of the plate (the beveled edges of the DCP® holes are not visible). Assemble the plate to the Plate Holding Tip by placing an end hole over the post on the back of the Plate Holding Tip and pressing it into place.

Turn the plate and holder over so that the retention fastener faces up. Secure the plate to the Plate Holding Tip using the cruciform screwdriver blade. Turn the re-tention fastener clockwise ¼ turn, so the arrow points to the “L” (locked) position.

RetentionFastener

Post

Turn retention fastener ¼ turn clockwise to lock plate into place.

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21 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

The plate may now be angulated left or right, as needed, by sliding the two-part grooved handle of the Articulating Plate Introducer between the thumb and forefinger.

IntraoralFracture Fixation

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386.905

Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 21

2 Position and contour the plate

Insert the Articulating Plate Introducer (with plate at-tached) through the intraoral incision and angulate the plate in the desired orientation. Position the plate along the posterior border of the mandible, allowing for a minimum of two screws to be placed on either side of the fracture. Three screws on either side of the fracture are optimal.

Once the plate is in the proper position over the frac-ture, evaluate any need for contouring. Remove the introducer and plate and contour the plate as needed to match the anatomy. Reinsert the plate and confirm that the contouring and the reduction are adequate.

The Hook, blunt, angled [386.905] may also be used to assist in positioning the plate.

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22 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

3 Temporarily fix the plate using the Manipulation Screw B 1.9 mm [386.902]

When the Manipulation Screw B 1.9 mm is used for temporary plate fixation, it must be inserted into the proximal fragment using the Handle, large, with mini quick coupling [311.013].

Insert the Manipulation Screw B 1.9 mm through the cannula into the most superior plate hole and thread into the bone. The Manipulation Screw B 1.9 mm must be fully inserted against the plate before manipulation of the fragment.

Precaution: This device should only be used in healthy bone with adequate bone stock to prevent splitting the bony margins.

Replace the screwdriver handle with the Handle for Manipulation Screw No. 386.902 [386.903] prior to manipulating fragment.

Intraoral Fracture Fixation

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 23

4 Drill first screw hole and place screw

Place the Drill Sleeve 1.5 [386.913] through the Drill Sleeve 2.0 with Trocar [386.914] and position the tip into the plate hole just distal to the fracture. Drill with the Drill Bit B 1.5 mm [316.520]. Remove the drill guide and insert the appropriate length 2.0 mm screw.

Note: Low-profile, right-angled drills can be used in this application.

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5

3

2

4

6

24 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

5 Drill and insert remaining screws

Insert the next screw into the plate hole just proximal to the fracture. Insert screws into all remaining visible plate holes. The sequence in Figure 1 is recommended.

IntraoralFracture Fixation

Figure 1

1 Manipulation Screw B 1.9 mm, self-drilling, length 80 mm

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 25

6 Remove the Articulating Plate Introducer

Remove the Articulating Plate Introducer from the plate by turning the retention fastener a ¼ turn counterclock-wise to the “U” (unlocked position).

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21 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

7 Drill and insert screw

Drill for the remaining distal hole and insert the appropriate length 2.0 mm screw.

Intraoral Fracture Fixation

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 27

8 Remove Manipulation Screw B 1.9 mm [386.902] and insert screw

Remove the Manipulation Screw B 1.9 mm [386.902] and insert the appropriate length 2.4 mm emergency screw through the 2.0 mm cannula and into the hole created by the Manipulation Screw B 1.9 mm.

Precaution: The Manipulation Screw B 1.9 mm [386.902] is single use only and should be discarded after use.

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28 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

9 Confirm reduction

Confirm proper reduction and inspect the anterior and posterior borders of the fracture through the endoscope.

IntraoralFracture Fixation

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Incision site

Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 29

SUBMANDIBULAR LESS INVASIVE APPROACH – SUBCONDYLAR FRACTURE REPAIR

1 Identify and mark landmarks

Prior to patient intubation, identify and mark the follow-ing relevant anatomic landmarks of the mandible and outline the fracture site or planned osteotomy:• Midline• Inferior border• Antigonial notch• Angle• Posterior border• Temporomandibular joint• Zygomatic arch• Anterior border• Superior border of the body• Sigmoid notch

PREPARATION

2 Mark incision site

Draw a line from the sigmoid notch, parallel to the posterior border, extending to the submandibular area, and mark a 1.5 cm incision parallel to the neck skin crease located at the angle of the mandible.

Precaution: It is important that the incision be at the mandible angle, to allow an endoscope to fit in the wound parallel to the anterior/posterior borders of the vertical ramus.

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Fracture

AssistantSurgeon

X

Monitor

Credit: Reid Mueller, MD

31 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

3 Position video monitor for endoscope

The top and both sides of the patient’s head must be ac-cessible to the surgeon and assistant. Position the video monitor for the endoscope at the head of the operating table towards the patient’s contralateral shoulder. The surgeon should stand on the ipsilateral side and the as-sistant on the contralateral side of the incision site.

4 Place patient in MMF

Place patient in temporary MMF with wire or elastic traction.

Precaution: Address other fractures, if present, prior to subcondylar fracture fixation.

Submandibular Less Invasive Approach – Subcondylar Fracture Repair

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 31

Submandibular

EXPOSURE AND CREATION OF THE OPTICAL CAVITY

1 Make a 1.5 cm submandibular incision

Make a 1.5 cm submandibular incision, 1.5 cm to 2.0 cm below the mandible angle, to avoid the marginal man-dibular branch of the facial nerve.

2 Dissect through the fascia

Spread the tissue with a curved hemostat down to the platysmal layer. Using Senn retractors, stretch the inci-sion both vertically and horizontally. With the retractors parallel to the wound and facial nerve, dissect through the fascia down to the masseter muscle plane.

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32 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

3 Extend the dissection to the bone

Extend the dissection down to the bone, and then supe-riorly in a subperiosteal plane. To increase the optical cavity and visualization, complete the dissection over the lateral surface of the proximal fragment after it is identi-fied.

Note: Use the Retractor, curved, double-ended [U44-48220] and Retractor, straight, double-ended [398.415] or Freer Suction Elevator [386.906] to max-imize visualization and access. Fit a suction tube onto the back end of the Freer Suction Elevator and activate suction by placing a finger over the port.

SubmandibularExposure and Creation of the Optical Cavity

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 33

4 Create optical cavity

Insert the Retractor, length 60 mm, width 8 mm [386.920] or Optical Retractor Handle with the appropri-ate retractor blade to obtain a limited temporary optical cavity.

5 Insert endoscope

Retract the soft tissue and insert the endoscope, with matching irrigating sheath, into the optical cavity. Lighted telescopes, of 2.7 mm through 4.0 mm diameter and with 30° or 45° angles, are commonly used for this application.

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34 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

6 Carry dissection proximally

Carry the periosteal dissection proximally, using the double-ended elevators or the Freer Suction Elevator [386.906] to maximize visualization and access. Continue dissection along the posterior border and over the lateral surface of the proximal fragment after it is identified.

Note: Fit a suction tube onto the back end of the Freer Suction Elevator and activate suction by placing a finger over the port.

SubmandibularExposure and Creation of the Optical Cavity

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386.915

386.917

5C

5A

5D

5B

Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 35

7 Assemble the optical retractor

Insert the endoscope with sheath into the assembled optical retractor.

Note: The optical retractor assembly consists of two parts, the Handle for Optical Retractor [386.915] which accepts a lighted endoscope with sheath (2.7 mm– 4.0 mm), and an Insert for Optical Retrac-tor, available in two widths, 12 mm [386.917] and 17 mm [386.918]. The 12 mm blade is typically used for the submandibular approach, requiring a smaller extraoral incision.

To assemble the retractor, first place the appropriate Retractor Blade into the coupling nut on the Optical Re-tractor Handle and secure by finger tightening the nut (Fig. 5A). Then insert the endoscope with sheath into the securing clamp on the Optical Retractor Handle (Fig. 5B). Position the endoscope so that the preferred view is ob-tained. Secure by turning the knob (Fig. 5C).

Attach the optional handle extension to the Optical Re-tractor Handle for alternate holding positions (Fig. 5D).

Precaution: To prevent damage to the endoscope, the appropriate sheath must be used.

Handle extension can be inserted on either side of the handle.

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31 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

8 Place the optical retractor assembly

Insert the hooked tip of the optical retractor assembly with endoscope into the sigmoid notch. Adjust the posi-tion of the scope for the best visualization.

Complete dissection of the proximal fragment as neces-sary for plate placement. Support of the retractor and endoscope can be transferred to an assistant.

Precaution: Sufficient periosteum must be elevated from the sigmoid notch to allow placement of the optical retractor.

SubmandibularExposure and Creation of the Optical Cavity

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 37

Optional Technique:

The Cheek Retractor Ring with thread, for No. 386.914 [386.908] when assembled to the 2.0 mm Threaded Cannula may be used as an alternative to the optical re-tractor assembly. The cannula will also provide a trans-buccal portal for drilling and passage of 2.0 mm screws.

Insert the Drill Sleeve 2.0 with Trocar [386.914] into the Universal Handle for Drill Sleeves [397.211].

Make a cutaneous puncture for the trocar placement at a point perpendicular to and directly over the subcondy-lar fracture line. A curved clamp may be inserted into the submandibular incision and the cheek pushed out over the fracture to identify the correct placement of the tro-car stab incision.

Precaution: The patient should not be paralyzed during insertion of the trocar so stimulation to the facial nerve can be identified and the trocar redi-rected if necessary. Initial spreading dissection with a clamp prior to trocar insertion is helpful.

Insert the cannula and obturator through thestab incision and press down to the bone.

Thread the Cheek Retractor Ring [386.908] onto the Drill Sleeve 2.0 with Trocar [386.914] using the Reduction Forceps for Fragments [386.912]. Rotate the cannula head clockwise to engage the ring on the threads of the cannula.

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386.912

38 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

Fracture reduction is often the most challenging part of the surgical procedure. Musculoskeletal forces typically drive the ramus superiorly resulting in proximal fragment override. Distracting the mandible inferiorly can signifi-cantly aid in reduction. Transverse fractures so reduced may provide sufficient interfragmentary friction to main-tain reduction during plating.

1 Distract the mandible

Distract the mandible, if necessary. This may be accom-plished by placing a straight elevator between the patient’s molars and rotating it. Distraction may also be achieved through the submandibular portal, using the Reduction Forceps for Fragments [386.912] to grasp the angle and distract as needed. Release MMF elastic if necessary but reapply after reduction.

Submandibular

FRACTURE REDUCTION

Straight Elevator

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 39

Note: Distraction can also be achieved by passing wire through a predrilled hole at the angle, twisting the free ends, and pulling inferiorly. This reduces the number of instruments through the incision.

Credit: Reid Mueller, MD

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41 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

2Reduce the fracture

Option 1Reduce the laterally displaced proximal fragment by ma-nipulating it medially. Use the obturator tip, Freer eleva-tors, or Fragment Manipulating Forceps to aid reduction.

Submandibular Fracture Reduction

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 41

Option 2

Use the Subcondylar Elevator, right angled [386.910] or left angled [386.911] to laterally reduce a medially dis-placed fragment.

Option 3

Reduction can also be achieved by using the Manipula-tion Screw B 1.9 mm [386.902] with the Handle for Manipulation Screw No. 386.902 [386.903].

First insert the Drill Sleeve 2.0 with Trocar, self-holding [386.904] through a trocar incision at a suitable location superior to the fracture line, where the top plate hole will be located. Remove the obturator and insert the Manipulation Screw B 1.9 mm through the self-retaining 2.0 mm Cannula.

Precaution: The patient should not be paralyzed during insertion of the trocar so stimulation to the facial nerve can be identified and the trocar redi-rected if necessary. Initial spreading dissection with a clamp prior to trocar insertion is helpful.

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42 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

The Manipulation Screw B 1.9 mm [386.902] is self- drilling and must be fully inserted into the proximal frag-ment using the Handle, large, with mini quick coupling [311.013].

Precaution: This device should be used only in healthy bone in an area with adequate bone stock to prevent splitting the bony margins.

Prior to manipulation of the bone, replace the screw-driver handle with the lightweight Fragment Manipulator Handle for manipulation and reduction of the proximal fragment.

Precaution: If the screwdriver handle is not re-placed, loss of reduction and bending of the Manip-ulation Screw B 1.9 mm may occur.

Gently manipulate the fracture fragment until reduction is achieved.

Note: See Step 3, page 46, for use of the Manipula-tion Screw B 1.9 mm in conjunction with a plate.

Submandibular Fracture Reduction

Manipulation Screw B 1.9mm, self-drilling, length 80 mm (386.902)

Use 311.013 Handle, large, with mini quick coupling for insertion of 386.902

Use 386.903 handle for manipulation Screw No. 386.902

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 43

Submandibular

FRACTURE FIXATION

Stable fracture fixation may be achieved using a 2.0 mm Dynamic Compression Plate affixed with a minimum of two screws, but preferably three screws, on either side of the fracture.

1 Load plate onto Articulating Plate Introducer

Load the desired 2.0 mm plate onto the flexible Plate Holding Tip of the Articulating Plate Introducer [386.900] by first ensuring that the “U” (unlocked posi-tion) on the retention fastener is aligned with the arrow on the Plate Holding Tip. The Screwdriver Shaft 1.5/2.0, cruciform, self-holding [314.442] with the Handle, large, with mini quick coupling [311.013], may be used to achieve alignment if necessary.

Turn the Plate Holding Tip so the cruciform retention fas-tener faces downward. Turn the selected Dynamic Com-pression Plate over to view the underside of the plate (the beveled edges of the DCP holes are not visible). As-semble the plate to the Plate Holding Tip by placing an end hole over the post on the back of the Plate Holding Tip and pressing it into place.

Turn the plate and holder over so that the retention fas-tener faces up. Secure the plate to the Plate Holding Tip, using the cruciform screwdriver blade. Turn the retention fastener clockwise 1/4 turn, so the arrow points to the “L” (locked) position.

RetentionFastener

Post

Turn retention fastener 1/4 turn clockwise to lock plate into place.

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44 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

The plate may now be angulated left or right, as needed, by sliding the two-part grooved handle of the Articulating Plate Introducer between the thumb and forefinger.

Submandibular Fracture Fixation

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386.905

Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 45

2Position and contour the plate

Insert the Articulating Plate Introducer (with plate at-tached) through the submandibular incision and angu-late the plate in the desired orientation. Position the plate along the posterior border of the mandible, allow-ing for a minimum of two screws to be placed on either side of the fracture. Three screws on either side of the fracture are optimal.

Once the plate is in the proper position over the frac-ture, evaluate any need for contouring. Remove the in-troducer and plate, and contour the plate as needed to match the anatomy. Reinsert the plate and confirm that the contouring and the reduction are adequate.

The Hook, blunt, angled [386.905] may also be used to assist in positioning the plate.

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386.903

41 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

3Temporarily fix the plate using the Manipulation Screw B 1.9 mm [386.902]

When the Manipulation Screw B 1.9 mm is used for temporary plate fixation, it must be inserted into the proximal fragment using the screwdriver Handle, with mini quick coupling [311.013].

Insert the Manipulation Screw B 1.9 mm through the cannula into the most superior plate hole, and thread into the bone. The Manipulation Screw B 1.9 mm must be fully inserted against the plate before manipulation of the fragment.

Precaution: This device should only be used in healthy bone with adequate bone stock to prevent splitting the bony margins.

Replace the screwdriver handle [311.013] with the Handle for Manipulation Screw No. 386.902 [386.903] prior to manipulating fragment.

Submandibular Fracture Fixation

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 47

4Drill first screw hole and place screw

Place the Drill Sleeve 1.5 [386.913] through the Drill Sleeve 2.0 with Trocar [386.914] and position the tip into the plate hole just distal to the fracture. Drill with the Drill Bit B 1.5 mm [316.520]. Remove the drill guide and insert the appropriate length 2.0 mm screw.

Note: Low-profile, right-angled drills can be used in this application.

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5

3

2

4

6

48 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

5Drill and insert remaining screws

Insert the next screw into the plate hole just proximal to the fracture. Insert screws into all remaining visible plate holes. The sequence in Figure 1 is recommended.

Submandibular Fracture Fixation

Figure 1

1 Manipulation Screw B 1.9 mm, self-drilling, length 80 mm

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 49

6Remove the Articulating Plate Introducer

Remove the Articulating Plate Introducer from the plate by turning the retention fastener ¼ turn counterclock-wise, to the “U” (unlocked position).

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51 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

7Drill and insert screw

Drill for the remaining distal hole and insert the appro-priate length 2.0 mm screw.

Submandibular Fracture Fixation

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 51

8Remove Manipulation Screw B 1.9 mm and insert screw

Remove the Manipulation Screw B 1.9 mm and insert the appropriate length 2.4 mm emergency screw through the 2.0 mm cannula and into the hole created by the Manipulation Screw B 1.9 mm.

Precaution: The Manipulation Screw B 1.9 mm is single use only and should be discarded after use.

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52 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

9Confirm reduction

Confirm proper reduction and inspect the anterior and posterior border of the fracture through the endoscope.

Submandibular Fracture Fixation

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Subcondylar Ramus Fixation Set Surgical Technique DePuy Synthes 53

SUBCONDYLAR RAMUS FIXATION SET[115.680]

690.600 Graphic Case for Fixation Set for Subcondyles and for Ramus

304.679 Module Compact 2.0 Fixation System, with Lid, without Contents

Instruments

311.013 Handle, large, with mini quick coupling

314.442 Screwdriver Shaft 1.5/2.0, cruciform, self-holding, length 92 mm

316.520 Drill Bit B 1.5 mm, length 125 mm, 2-flute, for J-Latch Coupling

321.170 Pin Wrench B 4.5 mm, length 120 mm

347.980 Holding Forceps for Plates

386.900 Plate Holder, adjustable, complete

386.901 Tip for Plate Holder No. 386.900

386.902 Manipulation Screw B 1.9 mm, self-drilling, length 80 mm

386.903 Handle for Manipulation Screw No. 386.902

386.904 Drill Sleeve 2.0 with Trocar, self-holding, length 62 mm

386.905 Hook, blunt, angled, B 1.5 mm

386.906 Freer Suction Elevator, with Cleaning Stylet B 1.8 mm

386.908 Cheek Retractor Ring, with thread, for No. 386.914

386.910 Subcondylar Elevator, right angled

386.911 Subcondylar Elevator, left angled

386.912 Reduction Forceps for Fragments, with Points, narrow, ratchet lock, length 210 mm

386.913 Drill Sleeve 1.5, length 67 mm

386.914 Drill Sleeve 2.0 with Trocar, with thread, length 72 mm

386.915 Handle for Optical Retractor

386.917 Insert for Optical Retractor, width 12 mm

386.918 Insert for Optical Retractor, width 17 mm

386.920 Retractor, length 60 mm, width 8 mm

397.211 Universal Handle for Drill Sleeves

398.415 Retractor, straight, double-ended, length 240 mm

U44-48220 Retractor, curved, double-ended, length 200 mm, size 1

Also Available

319.520 Depth Gauge for Screws B 1.5 to 2.0 mm, measuring range up to 45 mm

319.270 Cleaning Brush B 2.1 mm, for Cannulated Instruments

386.907 Cleaning Stylet B 1.8 mm, for No. 386.906

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54 DePuy Synthes Subcondylar Ramus Fixation Set Surgical Technique

SUGGESTED READING LIST

Anastassov, G., H. Lee, and R. Schneider. “Arthroscopic Reduction of a High Condylar Process Fracture: A Case Report.” Journal of Oral and Maxillofacial Surgery 58 (9): 1048–1051 (2000).

Barone, C., M. Boschert, and D. Jimenez. “Usefulness of Endoscopy in Craniofacial Trauma.” The Journal of Cranio-Maxillofacial Trauma 4 (3): 36–41 (1998).

Chen, C., J. Lai, T. Tung, and Y. Chen. “Endoscopically Assisted Mandibular Subcondylar Fracture Repair.” Plas-tic and Reconstructive Surgery 103 (1): 60–65 (1999).

Ellis, E., P. Simon, and G. Throckmorton. “Occlusal Results After Open or Closed Treatment of Fractures of the Mandibular Condylar Process.” Journal of Oral and Maxillofacial Surgery 58 (3): 260–268 (2000).

Jacobovicz, J., C. Lee, and P. Trabulsy. “Endoscopic Repair of Mandibular Subcondylar Fractures.” Plastic and Reconstructive Surgery 101 (2): 437–441 (1998).

Kellman, R. “Endoscopy in Craniomaxillofacial Skeletal Surgery.” Current Opinion in Otolaryngology and Head and Neck Surgery 9: 253–255(2001).

Lauer, G., and R. Schmelzeisen. “Endoscopic-Assisted Fixation of Mandibular Condylar Process Fractures.” Journal of Oral and Maxillofacial Surgery 57 (1): 36–39 (1999).

Lee, C., R. Mueller, K. Lee, and S. Mathes. “Endoscopic Subcondylar Fracture Repair: Functional, Aesthetic, and Radiographic Outcomes.” Plastic and Reconstructive Surgery 102 (5): 1434–1443 (1998).

Sandler, N. “Endoscopic-Assisted Reduction and Fixation of a Mandibular Subcondylar Fracture: Report of a Case.” Journal of Oral and Maxillofacial Surgery 59 (12): 1479–1482 (2001).

Schon, R., R. Gutwald, A. Schramm, N.-C. Gellrich, and R. Schmelzeisen. “Endoscopy-Assisted Open Treatment of Condylar Fractures of the Mandible: Extraoral vs. Intraoral Approach.” International Journal of Oral and Maxillofacial Surgery 31: 1–7, 2002.

Troulis, M., and L. Kaban. “Endoscopic Approach to the Ramus/Condyle Unit: Clinical Applications.” Journal of Oral and Maxillofacial Surgery 59: 503–509 (2001).

Troulis, M., O. Nahlieli, F. Castano, and L. Kaban. “Mini-mally Invasive Orthognathic Surgery: Endoscopic Vertical Ramus Osteotomy.” International Journal of Oral and Maxillofacial Surgery 29: 239–242 (2000).

Troulis, M., D. Perrott, and L. Kaban. “Endoscopic Man-dibular Osteotomy, and Placement and Activation of a Semiburied Distractor.” Journal of Oral and Maxillofacial Surgery 57 (9): 1110–1113 (1999).

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com 0123

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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