Pelvic Implants and Instruments. A dedicated system for ...synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · A dedicated system for reconstructive pelvic and

Pelvic Implants and Instruments. A dedicated system for reconstructive pelvic and acetabular surgery.

Surgical Technique

This publication is not intended for distribution in the USA.

Instruments and implants approved by the AO Foundation.

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WarningThis description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

Pelvic Implants and Instruments Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

MRI Information 65

Pelvic Implants and Instruments 2

Implant Specifications 4

AO Principles 6

Indications 7

Instruments – Standard 8– Retractors 10– Reduction 12

Plate Contouring 14– In-situ Plate Contouring 16

Fracture Fixation – A. Pubic Symphysis Fractures 18– B. Iliac Fractures 22– C. Acetabulum Two Column Fractures 28

Plates 38

Screws 43

Instruments 44

Optional Implants 51

Optional Screws 53

Optional Instruments 54

Other Available Pelvic Instruments and Implants 59from Synthes

2 DePuy Synthes Pelvic Implants and Instruments Surgical Technique

Pelvic Standard Instrument SetThe Pelvic Instrument Set has a wide range of standard instruments for screw insertion, plate adaptation (bending instruments) and fixation during reduction for preliminary and definitive stabilization of pelvic and acetabular fractures.

The complex anatomy of the pelvic ring and acetabulum involve complex surgical exposures and demands exact anatomical reduction to achieve positive functional results.

The AO and Synthes took this into consideration in develop-ing the Pelvic Implant and Instrument Sets.

Pelvic Implants and Instruments. A dedicated system for reconstructive pelvic and acetabular surgery.

Essential equipment for the surgical treatment of pelvic fractures

The Pelvic Implant and Instrument Sets contain a wide range of implants, reduction instruments, retractors and instru-ments for screw and plate fixation for the operative treat-ment of pelvic and acetabular fractures. All implants are available in 316L implant stainless steel, sterile and non ster-ile packaged.

Reconstruction Plate and Screw SetThe pelvic and acetabular low profile implants offer pre-shaped plate designs. Additional trays with locking compres-sion, wide angle (acetabular) and J-plates (pelvic brim) are also available. All plates can be three-dimensionally con-toured allowing them to be closely adapted to pelvic bone surfaces. Bending templates allow for easy manual adap-tation of the plates.


Pelvic Retractor SetA wide range of retractors (pelvic, Hohmann, sciatic nerve and malleable) within the Pelvic Retractor Set provide more options to aid the surgeon in achieving good visibility within the chosen approach.

Pelvic Reduction Instrument SetThe pelvic reduction forceps and other reduction instruments within the Pelvic Reduction Instrument Set are designed to aid the surgeon with fracture reduction of pelvic injuries.


Reconstruction PlatesOccasionally, pelvic osteosyntheses can be carried out using screws alone, but in the majority of cases lag screw fixations must be supplemented by one or more plates.

The bone surfaces in the pelvic region have a very complex topography. In order to achieve accurate fixation, the plates should be contoured to the bone surface. Poorly contoured plates can lead to fracture displacement when the screws are fully tightened through the plate.

The design of the reconstruction plates allow for contouring in all three planes.

Uniform cross-sectionImproved contourability

Implant Specifications

– Profile: 3.7 mm – Screw angulation: up to 30° – Holes: 3 –20 (straight) – Allow the use of cortex screws

and/or pelvic cortex screws 3.5 mm

Reconstruction Plates 3.5 with low profile

Reconstruction Plates 3.5 with wide Angle

– Low profile: 2.7 mm – Screw angulation: up to 25° – Holes: 3 –20 (straight),

6 –16 (curved), 10 –16 (J-shaped) – Reconstruction Plate with low pro-

file, curved: – Available in two radii (88 mm

and 108 mm) to fit the average pelvis of a female or male, respectively

– Allows the use of cortex screws and/or pelvic cortex screws 3.5 mm

– Reconstruction Plate with low profile, J-shaped: hybrid of curved and straight: – One leg of the plate is straight,

while the other leg is bent with a radius of 88 mm

– Left and right– Fits along pelvic brim, from

the pubic rami (curved part of the plate) to the SI joint (straight end of the plate)


Low profile and rounded edgesReduce the risk of soft tissue irritation.

Coaxial combi-holes in locking platesAllow the use of locking screws or cortex screws in the same round conical plate hole.

– Profile: 3.7 mm – Screw angulation:

up to 12° (cortex screws) – Holes: 3 – 20 (straight),

10 – 16 (J-shaped) – Features coaxial combi-holes (this

means the plate can be used with standard cortex screws 3.5 as well as with 3.5 locking screws)

– Fits the anatomy of the pubic symphysis

– Coaxial combi-holes accept 3.5 locking screws as well as stan-dard/pelvic cortex screws (3.5)

– Radius of 60 mm – Reinforced midsection of plate – 3 small holes in midsection can be

used to attach sutures – 4 versions: – 4 coaxial combi-holes – 6 coaxial combi-holes – 2 DCU holes and 2 coaxial – combi-holes* – 2 DCU holes and 4 coaxial – combi-holes*

* DCU: Dynamic Compression Unit

– Reduces and stabilizes small bone fragments that are too small for screws.

– Can be used individually or with a 3.5 mm reconstruction plate.

– Pre-bent convex shape with two sharp spikes on the bottom surface. Reduction is achieved by sinking spikes into small fragments while tightening a screw through one of the screw holes.

– Convex shape for better bone reten-tion. Small fragments are preloaded once a screw is inserted which allows the plate to adapt better to bony, uneven surfaces.

– Allows the use of cortex screws and/or pelvic cortex screws 3.5 mm.

Locking Reconstruction Plate 3.5 Pubic Symphysis Plates 3.5 Spring Plate 3.5


AO Principles

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation:1, 2 Those principles as applied to the Pelvic Implants and Instruments are:

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Stable fixationStability by screw only or screw and plate fixation, as the personality of the fracture and the injury requires. The products provide purchase for required compression and stability.

Preservation of blood supplyPreservation of the blood supply to soft tissue and bone by careful handling and atraumatic surgery. Use of surgical technique that minimizes disruption of soft tissue and pre-serves vascular blood flow for bone healing.

Early, active mobilizationEarly and safe patient mobilization. The implants, combined with AO technique, provide stable fracture fixation with minimal trauma to vascular supply. Plate features combined with AO technique create an environment for bone healing, expediting return to function.

1 Müller ME, Allgöwer M, Schneider R, Willenegger H (1995) Manual of Internal Fixation. 3rd, expanded and completely revised ed. 1991. Berlin, Heidelberg, New York: Springer

2 Rüedi TP, Buckley RE, Moran CG (2007) AO Principles of Fracture Management. 2nd expanded ed. 2002. Stuttgart, New York: Thieme


Indications

Symphysis fractures – Pubic Symphysis Plates 3.5

Pelvic brim fractures – Reconstruction Plates 3.5 with low profile

– Straight Plates – Curved Plates (88 mm radius, 108 mm radius) – J-Plates

– Locking Reconstruction Plates 3.5 – Straight Plates – J-Plates

– Reconstruction Plates 3.5 with wide Angle – Straight Plates

Ilium/Iliac wing fractures – Reconstruction Plates 3.5 with low profile

– Straight Plates – Curved Plates (88 mm radius, 108 mm radius)

– Locking Reconstruction Plates 3.5 – Straight Plates

– Low Profile Reconstruction Plates 3.5 with wide Angle – Straight Plates

Acetabulum fractures – Reconstruction Plates 3.5 with low profile

– Straight Plates – Curved Plates (88 mm radius, 108 mm radius)

– Reconstruction Plates 3.5 with wide Angle – Straight Plates


Instruments for screw fixationScrew fixation of the pelvis requires the use of extra-long screws and corresponding instruments. The following instruments are part of the Pelvic Instrument Set:

– Extra-long 3-fluted calibrated drill bit – Extra-long taps, calibrated with depth markings – Extra-long screwdrivers (hexagonal and Stardrive) and

screwdriver shafts (hexagonal and Stardrive) – Extra-long depth gauge

Instruments – Standard

Bending instruments – The bending pliers should be used as the primary bending

instrument. – A smooth bend is best achieved by the introduction of

many small bends. – Bending irons, designed specifically for use with the

reconstruction plates, are also available.


Bending templates Malleable bending templates are available for all reconstruc-tion plate shapes (straight, curved, J-shaped). These can be fi tted to the reduced bone and then a plate is shaped to fi t the template. This helps to avoid repeated plate bending, which can cause micro cracks, therefore weakening the plate.

The templates can also be used to determine plate lengths.

In-situ bending instruments – In-situ bending instruments allow precise intraoperative

adaptation of the pre-bent reconstruction plate to the bone anatomy.

– The in-situ bending and twisting handles with different tips (straight, 90°, 120°) allow use in different surgical approaches.

03.100.090 In-situ Bender

03.100.091 In-situ Bending and Twisting Handle, straight

03.100.092 In-situ Bending and Twisting Handle, 90°



A wide range of malleable, blunt, spoon shaped, pelvic, Hohmann and sciatic nerve retractors provide more options to aid the surgeon with the chosen approach.

Instruments – Retractors


Radiolucent retractorsRadiolucent retractors allow for the passage of x-rays without having to remove the instrumentation in order to visualize the implant underneath. Another advantage of these retractors is their light weight.

In an effort to accommodate the surgeon needs, Synthes has redesigned several retractors in aluminum, thus making them radiolucent.


Instruments – Reduction

Pelvic reduction forcepsThe pelvic reduction forceps are designed to maximize the potential of the ilioinguinal and Kocher-Langenbeck ap-proaches. The jaws of all the larger forceps are long enough to accommodate the innominate bone, from the iliac crest to the pelvic brim, and can be used without exerting excess pressure on the iliac vessels.

Pelvic reduction forceps are equipped with features to im-prove handling characteristics during reduction maneuvers. – Pointed-ball tips prevent penetration of bone with a

thin cortex. – Longer spikes with sharper points provide a secure hold

on the pelvic surfaces.

Increased selection of forceps, including – Handles and jaws of different lengths – Straight and oblique versions

Ball spikes with pointed ball tipThe straight ball spikes facilitate reduction of bone frag-ments. They feature a spike to reduce the risk of the instrument slipping off the bone and a pointed-ball tip to prevent penetration of bone with a thin cortex.

Round and rectangular disksDisks can be used in conjunction with the reduction forceps with pointed ball-tips or the ball spike instruments. In poor quality bone (osteoporotic), they can aid in distributing the applied forces over a larger surface area in effort to prevent iatrogenic or compression fractures.


Pelvic reduction forceps for screwsAll forceps have been designed for use with 3.5 mm / 4.5 mm screws inserted on opposite sides of a fracture line, which allows the application of considerable reduction forces and manipulation in all three planes.

The large forceps have long handles for the transferal of large forces. The Farabeuf forceps can be either used with screws or as general bone forceps, i.e. to grasp and manipulate the iliac wing. – Jungbluth large (330 mm), small (250 mm),

for B 3.5 mm screws – Farabeuf medium (250 mm), small (190 mm),

for Cortex Screws B 3.5 and 4.5 mm

Reduction forceps with points These standard forceps can be applied directly to the bone’s surface, or be used with shallow drill holes or anchoring rings and hooks.

Medium and large bone hooksThe bone hooks are designed to allow the surgeon to mani-pulate the bone or bone fragments in order to ensure proper alignment and to achieve an anatomical reduction.

1

2


Plate Contouring

1Contour plate

Instruments

03.100.031 Bending Pliers for Reconstruction Plates 3.5

329.290 Bending Pliers for Reconstruction Plates 2.7 and 3.5

For plate contouring, place a plate between the ledge and the groove of the bending pliers. Place the concave surface on the side of pliers with the ledge. Squeeze the handles gradually and bend the plate as appropriate. (1)

For in-plane bending, place a plate into the groove of the bending pliers. Squeeze the handles gradually and bend the plate as appropriate. (2)


2Twist plate

Instruments


329.080 Bending Iron for Reconstruction Plates 3.5 and 4.5, length 190 mm


Hold the plate using the plier grips and twist the plate by using an additional bending iron.

Important: Avoid repeated bending and over bending as it weakens the plate. For reconstruction plates with coaxial combi-holes: use threaded pin to avoid screw hole deforma-tion during bending.

Note: The bending pliers (03.100.031) are intended for use with the Reconstruction Plates 3.5 contained in the Low Profile 3.5 mm Pelvic System. The bending pliers (329.290) are intended for use with the standard Reconstruction Plates 3.5.


In-situ Plate Contouring

In-situ bending instruments adjust the pre-bent, reconstruc-tion plates on the bone to match relevant patient anatomy during a surgical procedure. Using this instruments helps decrease the surgical time by reducing the need for repeated cycles of plate positioning and removal until the plate has been sufficiently shaped.

IndicationsThe instruments are intended for use with the following plate systems: – Reconstruction Plates 3.5 with low profile (straight,

curved and J-shaped) – Reconstruction Plates 3.5 with wide Angle – DCP Reconstruction Plates 3.5, straight and curved

ContraindicationsPlates with locking and coaxial combi-holes. In particular: – Locking Reconstruction Plates 3.5 – Pubic Symphysis Plates 3.5 – Spring Plates 3.5 – Reconstruction Plates 3.5 with coaxial combi-holes – Other plate sizes than 3.5 mm

Note: Preoperative pre-bending of the reconstruction plates is always required before in-situ plate bending. The in-situ bending instruments are intended for detailed and accurate adaptation of the plates to the local anatomy.

Notes – Do not bend the plate at the level of the holes. – Do not bend the plate multiple times at the same level

to avoid weakening of the plate.


2 Bend or twist plate

Instruments




Use two straight In-situ Bending and Twisting Handles.Place the tip of each handle in the plate hole. One handle is used for holding the plate while the second handle is mani-pulated to bend or twist the plate accordingly.

Note: The In-situ Bending and Twisting Handle, straight can be combined with the In-situ Bending and Twisting Handle, 90° or 120° where appropriate.

Note: Ensure that the tip of the instrument is properly attached to the plate to prevent slippage.

1 Contour plate: in-situ bending or correction of the bending radius

Instrument


Grasp the preliminary fixated plate with the in-situ bender. The nose and counter-bearing mouth of the bender must sit in the notches of the reconstruction plate.

Squeeze the handles and bend the plate as required.


Fracture Fixation

Note: The following cases of fracture fixation represent possible uses of pelvic instruments. Several applications are shown but other applications are possible.

A. Pubic Symphysis Fractures

1Approach

Use an anterior approach (e.g. Pfannenstiel or Stoppa).

1

2

3


2Reduce fracture

Instruments

399.980 Reduction Forceps, large, with Points, ratchet lock, length 200 mm

398.750 Pelvic Reduction Forceps, for use with Cortex Screws B 3.5 and 4.5 mm

398.880 Pelvic Reduction Forceps, large, adjustable, speed lock, length 300 mm

Achieve reduction of the pubic symphysis by using the large reduction forceps with points. (1)

Alternatively, achieve reduction by inserting two screws an-teriorly and using pelvic reduction forceps (398.750/398.880). (2,3)


Fracture Fixation

3Fix plate

Instruments

03.100.032 Ratcheting Handle with AO/ASIF Quick Coupling

03.100.033 Screwdriver Shaft, hexagonal, for Screws B 3.5 mm, length 250 mm

324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling

311.310 Tap for Cortex Screws B 3.5 mm, calibrated, length 175 mm Pre-drilling: B 2.5 mm

312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm

314.090 Holding Sleeve, for Nos. 314.070, 314.550 and 314.570

314.570 Screwdriver, hexagonal, small, B 2.5 mm, length 270 mm for Screws B 3.5 mm

315.920 Drill Bit B 2.5 mm, calibrated, length 230/205 mm, 3-flute, for Quick Coupling

319.091 Depth Gauge for Cortex Screws B 3.5 mm, measuring range up to 150 mm

511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling

Alternative instruments

03.100.045 Screwdriver Shaft Stardrive

314.115 Screwdriver Stardrive 3.5, SD15

1 2

3


Place the Pubic Symphysis Plate 3.5 over the symphysis joint and make a temporary fixation (e.g. with plate holding for-ceps).

According to preoperative planning and plate selection (locking/non-locking), use B 3.5 mm cortex screws and/or B 3.5 mm locking screws to fix the plate. If compression is needed between the symphysis joint, use the plate with DCU holes.

Insert the first cortex screw in the lateral part of DCU hole (eccentric). Insert the second cortex screw eccentrically into the DCU hole of the contralateral side of the pubic symph-ysis. (1,2)

Alternate tensioning of the screws results in compression of the symphysis.

Refer to the DCP and LC-DCP Systems technique guide (036.001.093) for more detailed steps during screw insertion and plate fixation.

Additional locking screws should be inserted according to the LCP Locking Compression Plate technique guide (036.000.019). (3)

Notes – The x-ray template 034.000.485 indicates locking screw

directions. – Refer to the DCP and LC-DCP Systems (036.001.093) and/

or LCP Locking Compression Plate (036.000.019) tech-nique guides for independent lag screw placement and plating.

– Screwdriver Shaft Stardrive (03.100.045) and Screwdriver Stardrive 3.5, SD15 (314.115) are used for B 3.5 mm Stardrive screws.


Fracture Fixation

B. Iliac Fractures

2Reduce fracture

Instruments

398.740 Pelvic Reduction Forceps, small, length 190 mm, for use with Cortex Screws B 3.5 and 4.5 mm

399.980 Reduction Forceps with Points, ratchet lock, length 200 mm

Confirm anatomical reduction of the anterior aspect of theiliac wing by finger palpation.

To reduce the iliac bone, use reduction forceps on the iliac crest and the posterior iliac wing.

1Approach

Use an anterior or posterior approach appropriate for the fracture pattern. The following example of an iliac fracture shows a possible fracture treatment using a posterior (Kocher – Langenbeck) approach.

1

2


Alternative technique

Instruments





398.750 Pelvic Reduction Forceps, medium, length 250 mm, for use with Cortex Screws B 3.5 and 4.5 mm


399.980 Reduction Forceps with Points, ratchet lock, length 200 mm

Alternatively, insert two temporary cortex screws on either side of the fracture line and gain compression using pelvic reduction forceps: 398.750 Farabeuf (1) or 398.880, Jungbluth (2).


Fracture Fixation

3Fix plate on posterior inferior ilium

Instruments








399.091 Bone Holding Forceps, self-centering, soft lock, length 191 mm





1 2

3 4


Insert a screw through the 4-hole low profile pelvic recon-struction plate into the body of the ilium, close to the sciatic notch. (1)

To reduce the posterior iliac fragment, insert a temporary screw into the posterior superior iliac spine. (2) Compress the fracture using the bone holding forceps. The forceps is therefore hooked into the most posterior plate hole and the temporary screw on the other side of the fracture line is used as a counter bearing. (3)

After additional screw fixation through the plate, remove the temporary screw. (4)

Notes – During fixation close to the greater sciatic notch, control

drill bit penetration and screw lengths with two-finger palpation to prevent damage to the nerve or vessels.

– Refer to the DCP and LC-DCP Systems (036.001.093) and/or LCP Locking Compression Plate (036.000.019) technique guide for independent lag screw placement and plating.


4Fix plate on iliac crest

Instruments

03.100.018 Ball Spike, straight, with pointed ball tips B 6.5 mm, length 300 mm












Fracture Fixation


Place a low profile pelvic reconstruction plate posterior to the iliac crest, and fix it with B 3.5 mm cortex screws.

The ball spike with pointed ball tip may also be used to achieve reduction.

Note: Refer to the DCP and LC-DCP Systems (036.001.093) and/or LCP Locking Compression Plate (036.000.019) technique guide for independent lag screw placement and plating.


C. Acetabulum Two Column Fractures

Fracture Fixation

1Approach

Use an ilioinguinal approach.

1

2

3


2Reduce fracture in iliac crest

Instruments

03.100.019 Ball Spike, straight, long, with pointed ball tips B 6.5 mm, length 400 mm

294.680 Schanz Screw B 6.0 mm, length 190/50 mm, Stainless Steel



Insert a Schanz screw into the proximal femur to allow intraoperative manual traction. (1)

Confirm anatomic reduction of the different fracture frag-ments. Fragments may be temporarily fixated with Kirschner wires. (2)

Different reduction instruments (e.g. ball spike, reduction forceps) may aid in achieving appropriate reduction. (2,3)


Fracture Fixation

3Insert screw in iliac crest

Instruments



310.370 Drill Bit B 3.5 mm, length 195/170 mm, 2-flute, for Quick Coupling












4Insert screw in body of ilium

Instrument

03.100.023 Pelvic Reduction Forceps, with pointed ball tips B 6.5 mm, length 400 mm

Insert a second lag screw into the body of the ilium perpendicular to the fracture line.

Use the pelvic reduction forceps to maintain reduction.

According to the DCP and LC-DCP Systems (036.001.093) technique guide for independent lag screw placement, insert a B 3.5 mm cortex screw (lag screw) into the iliac crest.

Use the pelvic reduction forceps and/or the large reduction forceps with points to maintain reduction.

Note: Use oscillating mode while drilling to avoid soft tissue damage and penetration of the anterior or posterior iliac cortex.

1


Fracture Fixation

Alternative technique

Instruments

03.100.020 Pelvic Reduction Forceps, with pointed ball tips B 6.5 mm, length 250 mm

03.100.022 Pelvic Reduction Forceps, angled, with pointed ball tips B 6.5 mm, length 240 mm

03.100.029 Bone Hook, medium, long, length 330 mm

03.100.120 Spiked Disc, round, hole 6.5 mm

314.291 Collinear Reduction Clamp (Sliding Mechanism)

398.753 Pelvic Arm, for Collinear Reduction Clamp

Alternatively the pelvic reduction forceps with pointed ball tips (straight or angled) can be used to reduce the fracture.

If necessary, spiked discs can be used with all pelvic reduc-tion forceps with ball tips. (1)

5Reduce posterior column

Instrument


Use the reduction forceps with points to reduce the frag-ment of the quadrilateral surface. The forceps bridge from the pelvic brim to the quadrilateral surface.

2

3


The collinear reduction clamp with pelvic arm is useful to reduce the posterior column. (2)

The bone hook placed beneath the ischial spine may also be used to reduce the posterior column. (3)


Fracture Fixation

6In-situ plate contouring

If preoperative bending is insufficient after plate positioning, insertion and tightening of the first screws, the in-situ ben-ding instruments can be used to further adapt the plate to the local anatomy.

Instruments





If in-situ plate adaptation is required, use the in-situ bender as described on page 17.


If plate needs to be bent or twisted to fit the local anatomy, the in-situ bending and twisting handles should be used as described on page 17.


7Fix plate on pelvic brim

Instruments






314.291 Collinear Reduction Clamp (Sliding Mechanism)




398.753 Pelvic Arm, for Collinear Reduction Clamp




Fracture Fixation


8Fix plate on pubic rami

Insert additional screws through the plate into the pubic rami to maintain reduction and stable fixation of the anterior column.

Note: Refer to the DCP and LC-DCP Systems (036.001.093) and/or LCP Locking Compression Plate (036.000.019) tech-nique guide for lag screw placement and plating.

Fix a J-plate with B 3.5 mm cortex screws on the pelvic brim according to the DCP and LC-DCP Systems (036.001.093) technique guide. Lag screws through the plate help to achieve a stable fixation between the anterior and posterior column.


Plates

Reconstruction Plate 3.5 with low profile, straight* – Stainless steel

Art. No. Holes Length (mm)

245.023 3 39

245.024 4 52

245.025 5 65

245.026 6 78

245.027 7 91

245.028 8 104

245.029 9 117

245.030 10 130

245.031 11 143

245.032 12 156

245.033 13 169

245.034 14 182

245.035 15 195

245.036 16 208

245.038 18 234

245.039 20 260

Reconstruction Plate 3.5 with low profile, curved (radius 108 mm)* – Stainless steel


245.876 6 78

245.878 8 104

245.880 10 130

245.882 12 156

245.884 14 182

245.886 16 208

* All implants are available sterile packed. For sterile implants add suffix “S” to article number.


Reconstruction Plate 3.5 with low profile, curved (radius 88 mm)* – Stainless steel


245.906 6 78

245.908 8 104

245.910 10 130

245.912 12 156

245.914 14 182

245.916 16 208

Reconstruction J-Plate 3.5 with low profile* – Stainless steel

Art. No. Direction Holes Length (mm)

245.920 right 10 130

245.922 right 12 156

245.924 right 14 182

245.926 right 16 208

245.930 left 10 130

245.932 left 12 156

245.934 left 14 182

245.936 left 16 208



Symphyseal Plate 3.5 with coaxial combi-holes* – Stainless steel


02.100.004 4 57

02.100.006 6 78

Symphyseal Plate 3.5 with coaxial combi-holes and 2 DCP* – Stainless steel


02.100.014 4 57

02.100.016 6 78

Reconstruction J-Plate 3.5 with coaxial combi-holes (radius 88 mm)* – Stainless steel

Art. No. Direction Holes Length (mm)

02.100.360 right 10 130

02.100.362 right 12 156

02.100.364 right 14 182

02.100.366 right 16 208

02.100.361 left 10 130

02.100.363 left 12 156

02.100.365 left 14 182

02.100.367 left 16 208

Plates



Reconstruction Plate 3.5 with coaxial combi-holes,straight* – Stainless steel


02.100.103 3 39

02.100.104 4 52

02.100.105 5 65

02.100.106 6 78

02.100.107 7 91

02.100.108 8 104

02.100.109 9 117

02.100.110 10 130

02.100.111 11 143

02.100.112 12 156

02.100.113 13 169

02.100.114 14 182

02.100.115 15 195

02.100.116 16 208

02.100.118 18 234

02.100.120 20 260



Reconstruction Plate 3.5 with wide Angle, straight* – Stainless steel


02.100.203 3 39

02.100.204 4 52

02.100.205 5 65

02.100.206 6 78

02.100.207 7 91

02.100.208 8 104

02.100.209 9 117

02.100.210 10 130

02.100.211 11 143

02.100.212 12 156

02.100.213 13 169

02.100.214 14 182

02.100.215 15 195

02.100.216 16 208

02.100.218 18 234

02.100.220 20 260

Spring Plate 3.5* – Stainless steel


02.100.301 1 19.5

02.100.302 2 31.5

02.100.303 3 43.5

Plates



Screws

02.200.010 –150 Cortex Screw Stardrive B 3.5 mm, self-tapping, length 10 –150 mm,

Stainless Steel*

204.630 –750 Pelvic Cortex Screw B 3.5 mm, self-tapping, head height 2.75 mm, length 30 –150 mm, Stainless Steel*

204.810 – 838 Cortex Screw B 3.5 mm, selftapping, length 10 – 38 mm, Stainless Steel*

213.010 – 095 Locking Screw B 3.5 mm, selftapping, length 10 – 95 mm, Stainless Steel*

02.200.003 Threaded Pin Stardrive B 3.5 mm, Stainless Steel*

Locking Screw Stardrive B 3.5 mm, self-tapping* – Stainless steel

Art. No. Length (mm)

212.101 10

212.102 12

212.103 14

212.104 16

212.105 18

212.106 20

212.107 22

212.108 24

212.109 26

212.110 28

212.111 30

212.112 32

212.113 34

212.115 36

Art. No. Length (mm)

212.116 38

212.117 40

212.119 45

212.121 50

212.123 55

212.124 60

212.125 65

212.126 70

212.127 75

212.128 80

212.129 85

212.130 90

212.131 95



Instruments

03.100.011 Pelvic Retractor, medium, length 268 mm

03.100.012 Pelvic Retractor, large, length 323 mm

03.100.013 Retractor for Sciatic Nerve

03.100.014 Retractor for Sciatic Nerve, long

03.100.015 Retractor, malleable, width 20 mm, length 330 mm




03.100.107 Radioluscent Pelvic Retractor, blunt, length 274 mm, Aluminium

03.100.108 Radioluscent Hohmann Retractor, width 35 mm, length 275 mm, Aluminium



03.100.111 Radioluscent Pelvic Retractor, medium, length 268 mm, Aluminium

03.100.112 Radioluscent Pelvic Retractor, large, length 323 mm, Aluminium

398.550 Pelvic Retractor, blunt

399.270 Bone Lever, long narrow tip, width 18 mm, length 235 mm

03.100.018 Ball Spike, straight, with pointed ball tips B 6.5 mm, length 300 mm





03.100.024 Pelvic Reduction Forceps, asymmetric, with pointed ball tips B 6.5 mm

03.100.027 Disc, round, hole B 6.5 mm

03.100.028 Disc, rectangular, hole B 6.5 mm

03.100.120 Spiked Disc, round, hole 6.5 mm

03.100.121 Spiked Disc, rectangular, hole B 6.5 mm


03.100.020 Pelvic Reduction Forceps with pointed ball tips B 6.5 mm, length 250 mm

03.100.023 Pelvic Reduction Forceps with pointed ball tips B 6.5 mm, length 400 mm

Instruments


398.750 Pelvic Reduction Forceps, medium, length 250 mm, for use with Cortex Screws B 3.5 and 4.5 mm


03.100.025 Pelvic Reduction Forceps, small, for Screws B 3.5 mm, length 250 mm


03.100.029 Bone Hook, medium, long, length 330 mm

03.100.030 Bone Hook, large, long, length 330 mm

398.520 Bone Hook, sharp, medium, length 230 mm

398.530 Bone Hook, sharp, large, length 200 mm


329.080 Bending Iron for Reconstruction Plates 3.5 and 4.5, length 190 mm


03.100.034 Bending Template for Low Profi le 3.5 Reconstruction Plates, straight, 20 holes

03.100.035 Bending Template for Low Profi le 3.5 Reconstruction J-Plates, 16 holes

03.100.036 Bending Template for Low Profi le 3.5 Reconstruction Plates, curved (R88), 16 holes

03.100.037 Bending Template for Low Profi le 3.5 Reconstruction Plates, curved (R108), 16 holes

Instruments






324.031 Plate Holder with thread B 3.5 mm, long

03.100.040 LCP Drill Sleeve 3.5, short, with thread, for Drill Bits B 2.8 mm

312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm


324.210 Drill Bit B 2.5 mm, calibrated, length 300 mm, with Quick Coupling, for Percutaneous Insertion

324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling

310.288 Drill Bit B 2.8 mm, length 165 mm, for AO/ASIF Quick Coupling



311.310 Tap for Cortex Screws B 3.5 mm, calibrated, length 175 mm

311.431 Handle with Quick Coupling



314.116 Screwdriver Shaft Stardrive 3.5, SD15, self-holding, for AO/ASIF Quick Coupling

03.100.045 Screwdriver Shaft Stardrive 3.5, SD15, length 250 mm, for AO/ASIF Quick Coupling

511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling

393.100 Universal Chuck with T-Handle

398.650 Pliers for Screw Removal, length 205 mm

Instruments


319.970 Screw Forceps, self-holding, length 85 mm


314.570 Screwdriver, hexagonal, small, B 2.5 mm, length 270 mm



Optional Implants

DCP 4.5, narrow* – Stainless steel


224.020 2 39

224.040 4 71

LC-DCP 4.5, narrow* – Stainless steel


224.520 2 34

224.530 3 52

224.540 4 70

Reconstruction Plate 4.5, straight*X = 2: Stainless steelX = 4: Titanium


X29.330 3 45

X29.340 4 61

X29.350 5 77

X29.360 6 93

X29.370 7 109

X29.380 8 125

X29.390 9 141


X29.400 10 157

X29.410 11 173

X29.420 12 189

X29.430 13 205

X29.440 14 221

X29.450 15 237

X29.460 16 253



Reconstruction Plate 3.5, straight*X = 2: Stainless steelX = 4: Titanium


X45.150 5 58

X45.160 6 70

X45.170 7 82

X45.180 8 94

X45.190 9 106

X45.000 10 118

X45.020 12 142

X45.040 14 166

X45.060 16 190

X45.080 18 214

X45.100 20 238

X45.120 22 262

Pelvic Reconstruction Plate 3.5, curved*X = 2: Stainless steelX = 4: Titanium


X45.300 6 70

X45.310 8 94

X45.320 10 118

X45.330 12 142

X45.340 14 166

X45.350 16 190

X45.360 18 214


Optional Implants


Optional Screws

Cortex Screws*X = 2: Stainless steel X = 4: Titanium

X04.810 – 930 Cortex Screw B 3.5 mm, self-tapping, length 10 – 130 mm

X14.814 – 940 Cortex Screw B 4.5 mm, self-tapping, length 14 – 140 mm

Cancellous Bone Screws*X = 2: Stainless steel X = 4: Titanium

X06.010 – 060 Cancellous Bone Screw B 4.0 mm, fully threaded, length 10 – 60 mm

X07.010 – 060 Cancellous Bone Screw B 4.0 mm, short thread, length 10 – 60 mm

X16.030 –120 Cancellous Bone Screw B 6.5 mm, thread length 16 mm, length 30 –120 mm

X17.045 –150 Cancellous Bone Screw B 6.5 mm, thread length 32 mm, length 45 –150 mm

X18.020 –110 Cancellous Bone Screw B 6.5 mm, fully threaded, length 20 –110 mm

294.680* Schanz Screw B 6.0 mm, length 190/50 mm, Stainless Steel

X19.980* Washer B 7.0/3.6 mm, for Screws B 2.7 to 4.0 mm



Optional Instruments

398.550 Pelvic Retractor, blunt

398.710 Spiked Disc, for Reduction Forceps

398.712 Disc for Reduction Forceps, rectangular

398.730 Pelvic Reduction Forceps, asymmetric, with pointed ball tips, length 400 mm

398.840 Pelvic Reduction Forceps, angled, small, with pointed ball tips, speed lock, length 190 mm

398.850 Pelvic Reduction Forceps, angled, large, with pointed ball tips, speed lock, length 230 mm

398.860 Pelvic Reduction Forceps, long, with pointed ball tips, speed lock, length 400 mm

398.870 Pelvic Reduction Forceps, long, with three pointed ball tips, speed lock, length 400 mm

398.890 Pelvic Reduction Forceps, with angled pointed ball tips, speed lock, length 250 mm


398.540 Ball Spike, with pointed ball tip, length 300 mm

399.092 Reduction Forceps, large, with Points, soft lock, length 222 mm

399.850 Pelvic Osteotomy Chisel, width 15 mm, length 304/134 mm

399.860 Pelvic Osteotomy Chisel, width 20 mm, length 304/134 mm


329.640 Bending Template for Straight Reconstruction Plates 3.5

329.660 Bending Template for Curved Reconstruction Plates 3.5

329.680 Bending Template for Straight Reconstruction Plates 4.5, to be cut

391.968 Shortcut 2.7 to 4.5, without rasp, for Reconstruction Plates 2.7 to 4.5, required in pairs

391.969 Shortcut 2.7 to 4.5, with Rasp, for Reconstruction Plates 2.7 to 4.5, required in pairs






310.300 Drill Bit B 3.2 mm, length 180/165 mm, 2-flute, for Jacobs Chuck











319.090 Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm

311.320 Tap for Cortex Screws B 3.5 mm, length 110/50 mm





311.470 Tap for Cortex Screws B 4.5 mm, calibrated, length 175 mm

314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm

314.070 Screwdriver, hexagonal, small, B 2.5 mm, with Groove

314.550 Screwdriver Shaft, hexagonal, small, B 2.5 mm, length 165 mm, for Quick Coupling

314.150 Screwdriver Shaft, hexagonal, large, B 3.5 mm

314.260 Screwdriver, hexagonal, large, B 3.5 mm, with Groove, length 300 mm

314.280 Holding Sleeve, large, for Nos. 314.190, 314.240, 314.260, 314.270 and 314.750

314.560 Screwdriver Shaft, hexagonal, large, B 3.5 mm, length 165 mm, for Quick Coupling



Other Available Pelvic Instruments and Implants from Synthes

Collinear Reduction Clamp SetThe Collinear Reduction Clamp assists in achieving and main-taining fracture reduction in minimally invasive techniques. The system consists of sliding mechanism, attachable arms and reduction attachments according to the clinical needs.

Refer to technique guide: 036.000.253.

Cannulated Percutaneous Guiding System SetThe Cannulated Percutaneous Guiding System is a soft tissue protector to assist in pelvic and acetabular reconstructive surgery. It allows for less invasive placement of 3.5 mm cor-tex or pelvic screws as well as 4.0 cancellous screws. It accepts temporary fixation with Kirschner wires / guide wires up to B 2.8 mm.




Pelvic C-ClampThe Pelvic C-Clamp is an emergency stabilization instrument for unstable injuries and fractures of the pelvic ring. Unstable pelvic ring fractures can be associated with massive loss of blood that can cause terminal shock. The Pelvic C-Clamp allows rapid reduction and stabilization of these unstable pelvic ring fractures, thus assisting the surgeon to gain con-trol of the shock reaction. This neither delays nor hinders subsequent diagnosis and therapy.

Note: The Pelvic C-Clamp is not contained in the pelvic sets. See separate Synthes publication “Pelvic C-Clamp”. Refer to technique guide: 036.000.899.

Large External FixatorIndications for stabilizing the anterior pelvic ring with a large external fixator are: Unstable fractures in the anterior pelvic ring, or symphysis fractures with or without participa-tion of the posterior pelvic ring. This type of stabilization is also possible in emergencies such as polytrauma, open wounds and, where appropriate, as an alternative to internal osteosynthesis.

The pelvis can be stabilized with an external fixator both at the iliac crest and the supraacetabular region.

The clamps are magnetic resonance conditional. This allows magnetic resonance examinations of patients who have been stabilized with the external fixator.



Spring Plate 3.5The Synthes Spring Plate 3.5 is intended for reduction and fixation of small bone fragments.

In pelvic and acetabular surgery, it is often difficult to reduce and fix small bone fragments with screws because the fragments may break into even smaller pieces. Mainly in the joint areas (acetabulum) it is essential that even small frag-ments are anatomically reduced and help to achieve again a homogenous joint congruency. The 3.5 Spring Plates are in-tended to reduce and stabilize bone fragments that are too small for screws. They can be used individually or in con-junction with a 3.5 mm reconstruction plate.


Sacral BarsThe Synthes 6.0 mm Threaded Sacral Bars offer an additional option for stabilization of the posterior pelvic ring. Two threaded bars are therefore drilled through the poste-rior iliac crests and by compression of the nuts, bridging and compression of the posterior pelvic ring is achieved.

Note: Two 6.0 mm Threaded Sacral Bar Kits are necessary to build the construct described in the technique guide (01.100.763 Sacral Bar Set, Bar Length 200 mm, sterile or 01.100.766 Sacral Bar Set, Bar Length 260 mm, sterile). Also, bolt cutters capable of cutting a 6.0 mm bar will be neces-sary to complete the procedure (Rod Cutter 388.720 is avai-lable). Refer to technique guide: 036.000.740.



Trocar for Cannulated Screws 6.5 and 7.3 mmThe trocar for 6.5 mm / 7.3 mm cannulated screws is in-tended to be used as a drill sleeve for a 2.8 mm guide wire and as a reduction tool, especially in minimally invasive procedures.

In addition to the existing guide handle for Kirschner wires B 2.5 (03.306.009) the new trocar features a pointed tip that provides better traction when used on an irregular bony surface.

The length of the standard trocar for cannulated screws is 300 mm and the long trocar for cannulated screws is 350 mm long. (314.052/314.054)

Curved Pelvic Osteotomy ChiselsThe Curved Pelvic Osteotomy Chisels are general surgical instruments, designed specifically for peri-acetabular osteotomies and are available in 15 mm and 20 mm widths with a smooth curve. (03.100.038/03.100.039)

These instruments feature an improved shape (curved in-stead of angled) compared to the existing Pelvic Osteotomy Chisels (399.850 and 399.860).


Curved Chisel BladesThe Curved Chisel Blades are primarily used to reshape the femoral neck. The four Chisel Blades are a line extension to the already existing straight Chisel Blades (399.550 – 399.580).

The Curved Chisel Blades feature a curved working end and are used in conjunction with the conventional chisel handle (399.540).

03.100.115 Curved Chisel Blade 5 mm





Periosteal ElevatorsThe Periosteal Elevators are basic surgical instruments and are available in 6 mm and 14 mm width curved blades and 14 mm and 20 mm width straight blades. They are designed to simplify the dissection and atraumatic exposure of the bone. They serve to free the bone surface from soft tissues in order to prepare the fracture surfaces for definitive fixa-tion. (399.350/399.380)

width length

03.100.041 Periosteal Elevator, curved blade 6 mm 200 mm

03.100.042 Periosteal Elevator, curved blade 14 mm 200 mm

03.100.043 Periosteal Elevator, straight blade 14 mm 200 mm

03.100.044 Periosteal Elevator, straight blade 20 mm 200 mm

399.350 Periosteal Elevator, curved shaft, 14 mm 190/75 mm round edge

399.360 Periosteal Elevator, slightly curved 6 mm 190/90 mm

blade, round edge

399.370 Periosteal Elevator, straight shaft, 14 mm 202/80 mm round edge

399.380 Periosteal Elevator, straight shaft, 20 mm 202/80 mm round edge



MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils [whole body averaged specific absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)].

Precautions: The above mentioned test relies on non-clini-cal testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients under-

going MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning proce-dures.

– Generally it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

0123

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

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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Pelvic Implants and Instruments. A dedicated system for ...synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · A dedicated system for reconstructive pelvic and