Total Compression Plate System - eMedia 5 Intended 2 Use Indications The Wright Total Compression Plate System - Ankle Fracture, is intended for fixation of factures, osteotomies,

TCPTotal Compression Plate System

ANKLE FR AC TURE SURGIC AL TECHNIQUE

Contents

Wright recognizes that proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training, experience, and patient condition. Prior to use of the system, the surgeon should refer to the product Instructions For Use package insert (152151) for additional warnings, precautions, indications, contraindications and adverse effects. Instructions For Use package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the Instructions For Use package inserts are available on wmt.com under the link for Prescribing Information.

Please contact your local Wright representative for product availability.

Chapter 1 4 Product Information

4 Device Description

Chapter 2 4 Intended use

5 Indications

Chapter 3 6 Surgical Technique

6 Ankle Fracture System Surgical Technique

6 Using the Compression or Distraction Clamp

9 Postoperative Protocol

9 Explant Information

Appendix A 10 Ordering Information

3

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1Product Information

Device Description

The Wright Medical Total Compression Plate System - Ankle Fracture is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of long bones and bone fragments. The system includes bone screws and manual surgical instruments which facilitate implantation and compression.

Chapter 1 Product Information4

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5

2Intended Use

Indications

The Wright Total Compression Plate System - Ankle Fracture, is intended for fixation of factures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system..

Prior to use of the system, the surgeon should refer to the product instructions for use package insert (152151) for warnings, precautions, indications, contraindications and adverse effects. Instructions for use package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the instructions for use package inserts are available on wmt.com under the link for Prescribing Information.

Chapter 2 Intended Use

6 Chapter 3 Surgical Technique

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Surgical Technique 3

Incision

Several incision options are available for ankle fractures. Preoperative fluoroscopy and/or CT scan should be used in determining the proper approach.

Incision location should take into account the fracture type and anatomy. FIGURE 1

FIGURE 1

Anatomic reduction is performed and length restored. In cases of comminution and bone loss, the contralateral ankle is used as a reference for accuracy.

Temporary fixation of the bone is achieved using TCP Ankle Fracture System. Care is taken to ensure that the location of the forceps do not interfere with the planned location of the implant/s. Anatomic reduction is confirmed fluoroscopically. FIGURE 2

FIGURE 2

Ankle Fracture Surgical Technique

Implant Selection: Plates

Like any lower extremity ORIF procedure, preoperative planning is vital to the overall outcome of ankle fracture fixation. Careful consideration must be given to implant selection. Choose an implant that addresses the specific needs dictated by the fracture location, fracture type, and classification. In addition, consideration must be given to the individual anatomic variables of the patient.

7PROFEMUR® RAZ Total Hip SystemChapter 3 Surgical Technique

Place the chosen TCP Ankle Fracture plate on the bone, ensuring adequate points of fixation can be achieved on all sides of the fracture line/s. Plate Wires (08-611) can be placed in the pin holes to achieve provisional plate fixation. Fluoroscopy should be used to verify accurate plate placement. FIGURE 3

FIGURE 3

FIGURE 4

Use the quick drill guide or locking drill guide with the correlating sized drill bit to create a pilot hole in preparation of screw insertion. Choose the appropriate diameter screw and screw type from either 2.7mm locking and non-locking or 3.5mm locking and non-locking. Use the 1.7mm Drill Bit (08-708) with the 2.7mm screws and the 2.5mm Drill Bit (08-709) with the 3.5mm screws. FIGURE 4

NOTE: If needed plate benders can be used prior to contour the plate to the bone.

PN Description

08-704 2.7mm Quick Drill Guide


08-702 2.7 Locking Drill Guide

08-703 3.5 Locking Drill Guide

Plate Wire 08-611

Drill Bit 08-708 — 709

8 Chapter 3 Surgical Technique

Once drill holes are complete, use the Depth Gauge (08-706) to determine the length of screw that is necessary. FIGURE 5

FIGURE 5

Once non-locking screws are in place drill the holes for the locking screws through the locking drill guides. Measure the depth for the screws and securely tighten the screws into the plate. FIGURE 6

FIGURE 6

Depth Gauge 08-706

It is recommended to take several images with fluoroscopy to ensure proper placement of the plate and length of the screws.

9Chapter 3 Surgical Technique

To use the screws, fixate one screw in the slot of the plate. Either proximal for compression or distal for distraction. Fixate another screw in the distal portion of the plate that aligns with the slot. Using the desired clamp either compress the fractured fragments together or distract the bone to ensure proper length.

If using the Compression/Distraction Clamps there must not be any screws placed through the plate prior to comp or distraction. Once the appropriate clamp has been utilized and the bone frags are where desired, fixate the plate with the desired locking or non-locking screws. FIGURE 7

FIGURE 7

PN Description

08-515 15mm Large Reduction Pin






Postoperative ProtocolPostoperative care is the responsibility of the medical professional.

Explant InformationRemoval of the plate may be performed by first extracting the plate and screws using the (08-701 TCP T10 Torx Driver) screwdriver and then removing the plate from the bone.

If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation.

Using the Compression or Distraction Clamp

If compression or distraction is desired use the TCP Reduction Pins in combination with the compression or distraction clamp.

10 Appendix A Ordering Information

Headline Headline A

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ix A

Ordering Information

PN Description

08-310 100mm Straight Plate

08-310L 100mm Distal Fibula Plate - Left

08-310R 100mm Distal Fibula Plate - Right

08-311 115mm Distal Tibia Plate












Implants

PN Description

08-701 TCP T10 Torx Driver

08-702 2.7mm Locking Drill Guide

08-703 3.5mm Locking Drill Guide



08-706 Depth Gauge

08-707 1.7mm/2.7mm Soft Tissue Protector

08-708 Ø 1.7mm Drill


08-709L Ø 2.5mm Drill (Long)

Instruments


08-711 2.7mm/3.5mm Countersink

08-712 Ø 2.7mm Drill (over)


08-714 8" Bone Clamp

08-715 6" Lobster Clamp

08-723 Large Plate Bending Pliers

08-724 Plate Bending Irons

08-725 Screw Pickup Forceps




03-4000-34 Non-Ratcheting Silicone Handle

03-4000-35 Ratcheting Silicone Handle







08-611 3" Plate Wire

08-614 Compression Clamp

08-615 Distraction Clamp

08-616 Dental Pick

08-617 Pointed Bone Clamp

08-618 Hohmann Retractor

08-619 Periosteal Elevator

08-621 1.1mm x 4" K-wire

08-622 1.6mm x 4" K-wire

08-623 1.6mm x 6" K-wire

11

PN Description

07-410 2.7 X 10MM NL SCREW

07-412 2.7 X 12MM NL SCREW

07-414 2.7 X 14MM NL SCREW

07-416 2.7 X 16MM NL SCREW

07-418 2.7 X 18MM NL SCREW

07-420 2.7 X 20MM NL SCREW

07-422 2.7 X 22MM NL SCREW

07-424 2.7 X 24MM NL SCREW

07-426 2.7 X 26MM NL SCREW

07-428 2.7 X 28MM NL SCREW

07-430 2.7 X 30MM NL SCREW

07-610 3.5 X 10MM NL SCREW

07-612 3.5 X 12MM NL SCREW

07-614 3.5 X 14MM NL SCREW

07-616 3.5 X 16MM NL SCREW

07-618 3.5 X 18MM NL SCREW

07-620 3.5 X 20MM NL SCREW

07-622 3.5 X 22MM NL SCREW

07-624 3.5 X 24MM NL SCREW

07-626 3.5 X 26MM NL SCREW

07-628 3.5 X 28MM NL SCREW

07-630 3.5 X 30MM NL SCREW

07-632 3.5 X 32.5MM NL SCREW

07-635 3.5 X 35MM NL SCREW

07-637 3.5 X 37.5MM NL SCREW

07-640 3.5 X 40MM NL SCREW

07-645 3.5 X 45MM NL SCREW

07-650 3.5 X 50MM NL SCREW

07-850 4.0 X 50MM NL SCREW

07-855 4.0 X 55MM NL SCREW

07-860 4.0 X 60MM NL SCREW

07-865 4.0 X 65MM NL SCREW

Non-Locking Screws

PN Description

07-510 2.7 X 10MM LOCKING SCREW






















07-732 3.5 X 32.5MM LOCKING SCREW


07-737 3.5 X 37.5MM LOCKING SCREW




Locking Screws

Appendix A Ordering Information

™Trademarks and ®Registered marks of Wright Medical Technology, Inc. ©2014 Wright Medical Technology, Inc.All Rights Reserved.

011189B 10-Dec-2014

Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117800 238 7117901 867 9971www.wmt.com

Wright Medical EMEAAtlas Arena, Australia BuildingHoogoorddreef 71101 BA Amsterdamthe Netherlands011 31 20 565 9060

Wright Medical UK Ltd.Unit 1, Campus FiveLetchworth Garden CityHertfordshire SG6 2JF United Kingdom011 44 (0)845 833 4435

Documents

Total Compression Plate System - eMedia 5 Intended 2 Use Indications The Wright Total Compression Plate System - Ankle Fracture, is intended for fixation of factures, osteotomies,