S U R G I C A L T E C H N I Q U E

SIDEKICKCORETRAK™ Tube Fixator

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Contents

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 and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the package insert is available on the website listed.

For product availability, please contact your local sales representative/distributor.

Intended Use

Surgical Technique

Explant Information

Ordering Information

Chapter 1 3

Chapter 2 4

Chapter 3 6

Chapter 4 7

INDICATIONSThe SIDEKICK™ CORETRAK™ Tube Fixator is indicated for stabilizing various fractures including open and/ or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones. The selection of the appropriate type of fixator is left to the discretion of the surgeon, according to the type of fracture. CONTRAINDICATIONSAbsolute contraindications include:• Physiologically or psychologically inadequate patient• Possibility for conservative treatment• Failure to obtain patient’s consent Conditions presenting increased risk of failure include:• Active infection• Inadequate skin, bone, or neurovascular status• Irreparable tendon system• Growing patients with open epiphyses• Patients with high levels of activity• Fevers and white blood cells• Obesity

Contraindications may be relative or absolute and are left to the discretion of the surgeon.

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Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the package insert is available on the website listed.

IntendedUse

The first pin is placed freehand perpendicular to the long axis of the bone. | FIGURE 1 The pin diameter should not exceed 1/3 of the bone diameter.

Place the fixator over the first pin and align the fixator so that the distal internal pin clamp is positioned over the bone. | FIGURE 2 The internal clamp should be adjusted along the length of the fixator to position the pin holes in the desired location.

Insert the second pin through the fixator which is used as a guide.| FIGURE 3 Use fluoroscopy to check pin penetration through the far cortex. Pins should not penetrate more than 2mm beyond the far cortex of bone.

Insert the third and fourth pins through the fixator in the same manner as the first two pins. An AO adaptor can be used to connect to the pins to assist with the insertion. | FIGURE 4 A hole in the adaptor allows the screwdriver to manually advance the pins (inset). Proximal pins can be positioned in either a vertical or horizontal configuration depending upon the anatomy.

Leave adequate clearance between the fixator and skin to allow for post-operative swelling.

Surgical Technique 1

FIGURE 1

FIGURE 2

FIGURE 3

FIGURE 4

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ter

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Lock the distal pins by tightening the set screws located within the fixator slot. | FIGURE 5

Lock the proximal pins by tightening the set screw in the proximal end of the fixator. | FIGURE 6

Compression or distraction can be obtained by turning the set screw located within the distal end of the fixator. | FIGURE 7 For compression, turn clockwise. For distraction, turn counterclockwise. For bone lengthening with a callotasis technique, the distraction should be divided into ¼ turn increments. One full turn of the screwdriver will result in 1mm of distraction. The screwdriver is marked with a directional arrow and turn indicators to assist with distraction. A graduated scale along the pin slot can be used to gauge overall length achieved.

After fixator application, the protruding ends of the pins should be cut short and capped with pin covers or if possible, the fixator pin clamps can be temporarily loosened so that the fixator can be moved slightly away from the body to cover the cut ends of the pins. Perform a final check of all fixator components to ensure that they are tightened before completing the surgery.

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FIGURE 5

FIGURE 6

FIGURE 7

EXPLANT INFORMATION To remove the SIDEKICK™ CORETRAK™ Tube Fixator all set screws should be loosened to release the pins. The fixator is then removed from the pins and discarded. The pins are then removed in a counter clock wise direction out of the bone and discarded.

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.

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Ordering Information

Part No. Description

CORETRAK® Sterile Packed Kits XPCK1002 CORETRAK® Steripack ShortXPCK1300 CORETRAK® Steripack Standard (D 40mm)XPCK1303 CORETRAK® Steripack Long (D 70mm)XPCK1200 CORETRAK® Steripack ArticulatingEFSR1002 CORETRAK® Fixator ShortEFSR1300 CORETRAK® Fixator Standard (D 40mm)EFSR1303 CORETRAK® Fixator Long (D 70mm)EFSR1200 CORETRAK® Articulating FixatorEFSR5001 CORETRAK® Step Hex Driver 2.0/3.5mmEFSR5002 CORETRAK® Hex Driver 3.5mmEFSR5005 A/O Pin AdaptorEF301580 CORETRAK® Half Pin 3.0 x 80 x 15mm Thread TiN CoatedEF302580 CORETRAK® Half Pin 3.0 x 80 x 25mm Thread TiN CoatedRR101002 Pin Covers Medium 10/boxXP320100 CORETRAK® Halfpin 3.0 x 20 x 100mm Thread TiN Coated (Sterile)RR251580 Half Pin 2.5 x 15 x 80mm ThreadRRM5007 Half Pin Driver Extractor

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™ and ™ denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates.©2017 Wright Medical Group N.V. or its affiliates. All Rights Reserved.

010499B_17-Oct-2016

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