TORNIER DRLOCK EXTREME · proximal portion of the plate. See page 16 for catalog numbers and...

T R I B R I D™ T E C H N O L O G YS U R G I C A L T E C H N I Q U E

TORNIER

DRLOCK™ EXTREMEDistal Radius Plating System

™

Table of Contents:

3

Surgical Technique ................................................................................................................................................................................................4

Implants .................................................................................................................................................................................................................. 14

4

Step 1

Make a longitudinal incision directly over the flexor carpi radialis (FCR) tendon.

Step 2

Spread the subcutaneous tissue bluntly to expose the FCR tendon sheath. Incise the sheath directly over the tendon. Retract the tendon ulnarly to expose the deep aspect of the FCR tendon sheath.

Step 3

Identify the palmar branch of the radial artery in the distal aspect of the incision as it crosses radial to ulnar over the FCR tendon.

Step 4

Once the radial artery has been identified, incise the tendon sheath.

Step 5

Identify the tendons of the flexor digitorum superficialis (FDS) and retract them ulnarly.

Step 6

Identify the tendon of the flexor pollicis longus (FPL), and dissect it bluntly off of the fascia of the pronator quadratus. Sharp detachment of the distal origin of the FPL from the radial diaphysis may be required. Retract the FPL tendon radially.

Step 7

Expose the fracture site by identifying the pronator quadratus muscle belly and incise it from its radial attachment from distal to proximal.

Step 8

Use manual reduction maneuvers as well as fluoroscopic guidance to reduce the fracture. Guide wires may be used to obtain temporary stabilization of the fracture.

Surgical Technique

5

Step 9

Select the appropriately sized DRLOCK™ EXTREME™ plate. Standard and narrow width plates are available in both standard and short lengths for the left and right radius. Care must be taken not to scratch or notch the implants throughout the procedure. See page 14 for catalog numbers and descriptions.

Step 10

If necessary, use the bending pliers (MXS-051) to contour the plate to fit the bone surface. Each bend should be in one direction only. Reverse or over bending may cause reduced fatigue life. Avoid excessive bending through the locking holes. If the plate is contoured through a locking hole, a non-locking screw is recommended to avoid cross-threading of the fixed-angle locking screw or variable-angle locking PEEK Ring.

Step 11

Place the plate on the distal radius. Mate the contour of the plate to the volar aspect of the distal radius. The plate can be temporarily held in position with guide wires (DRV-040-11), which are provided in the set.

Step 12

The screw holes in the DRLOCK™ EXTREME™ plate are compatible with a variety of screw and peg options. For the distal holes, 2.0 mm fixed-angle locking pegs (green), 2.4 mm non-locking screws (green), 2.4 mm fixed-angle locking screws (green), and 2.4 mm variable-angle locking screws (blue) are offered. For the proximal portion of the plate, 3.5 mm non-locking screws (magenta) and 3.5 mm fixed-angle locking screws (magenta) are offered. 3.5 mm variable-angle locking screws (silver) are available for the proximal holes upon request. Only 3.5 mm non-locking screws can be used in the translation slot. Screw type is chosen based on indication and surgeon preference; a combination of screws may be used in the same plate. See pages 15–17 for catalog numbers and descriptions.

Left Short

Narrow

Right Short

Narrow

Left Standard Narrow

Right Standard Narrow

Left Standard

Right Standard

Left Short

Right Short

6

Step 13

Three color-coded drill bits are provided in the system: 1.6 mm (yellow), 1.9 mm (blue/green), and 2.4 mm (magenta) outer diameters. The 1.6 mm drill bit is to be used with the 2.4 mm variable-angle locking screws. The 1.9 mm drill bit is to be used in conjunction with the 2.0 mm fixed-angle locking pegs and the 2.4 mm non-locking and fixed-angle locking screws that fit in the distal portion of the plate. The 2.4 mm drill bit is to be used in conjunction with the 3.5 mm non-locking, fixed-angle locking, and variable-angle locking screws that fit in the proximal portion of the plate. See page 16 for catalog numbers and descriptions.

Step 14

Use the standard drill guide tip (MFT-171-24-C) and the drill guide handle (MFT-171) when drilling for 3.5 mm non-locking screws. Use the locking guide (MFT-071-24-FDG) or Key-way guide (MFT-071-24-KG) when drilling for 3.5 mm fixed-angle locking screws. Use the pre-loaded disposable 30° drill guide inserter (MXL-032-35) when drilling for 3.5 mm variable-angle locking screws. Use the standard drill guide tip (MXM-171-C) and handle (MFT-171) when drilling for 2.4 mm non-locking screws. Use either the locking guide (DRE-071-19-FDG) or the appropriate guide block (see chart) and drill guide (DRE-071-19-GB) when drilling for a 2.0 mm fixed-angle locking peg or 2.4 mm fixed-angle locking screw. For 2.4 mm variable-angle locking screws, see steps 24–25.

Note: The drill guides are color coded to match the appropriate drill bit; drill guides for the distal screw holes are green, blue, or yellow, and drill guides for the proximal screw holes are magenta.

Note: To use the drill guide tips, insert the desired guide tip into the handle.

GUIDE BLOCKS

Catalog # DescriptionDRE-071-GB-L Standard Left Plate

DRE-071-GB-R Standard Right Plate

DRE-071-GB-NL Narrow Left Plate

DRE-071-GB-NR Narrow Right Plate

7

Step 15

Place the first screw into the translation slot. Using the 2.4 mm drill bit and standard drill guide, drill a bicortical hole perpendicular to the plate.

Step 16

Use the provided single banded magenta depth gage (DRE-059-16) to determine the screw length. For all screws used throughout the procedure, verify the screw length in the appropriate gage on the screw caddy.

Step 17

Insert a 3.5 mm non-locking screw into the hole using the appropriate HEXSTAR™ driver (MXS-056T) and maroon ratcheting handle (DRV-057). Drive the screw approximately 3 revolutions to temporarily fix the plate to the bone. Confirm the correct positioning of the plate using fluoroscopy.

Note: The maroon handle is to only be used with the 3.5 mm proximal screws. The black handle is to be used with the 2.0 mm pegs and 2.4 mm distal screws.

Note: For translation slot and all proximal holes, use single banded magenta depth gage. The depth gage reading corresponds to the working length of the screw (from beneath the screw head to the distal tip).

8

Step 18

Guide wires may be used to determine direction of screw placement. Insert a guide wire into the distal temporary fixation hole of the plate near the radial styloid. Direct the guide wire toward the joint. This wire is directed at the same angle as the styloid screw hole. Insert another guide wire into the temporary fixation ulnar hole. Verify that the guide wires are not in the joint. If guide wires are in a joint or an undesirable location, use the slot to adjust the placement of the plate. When the desired location is achieved, tighten the screw in the translation slot using the standard two-finger finishing technique. Guide wires may also be used for temporary fixation in the proximal portion of the plate as well.

Step 19

If the locking guide is desired to insert the distal screws and pegs, thread the green threaded drill guide into the distal hole of the plate and drill using the 1.9 mm drill bit. Repeat for each desired hole.

Note: Only use the guide wires provided in the DRLOCK™ EXTREME™ System in conjunction with the plate. Allow the plate to guide the guide wire. Do not attempt to place the distal wires perpendicular to the plate.

9

Step 20

If the guide block method is desired to insert distal screws and pegs, select the appropriately sized guide block (see step 14 for chart). Attach the guide block to the plate using maroon handle and the proximal HEXSTAR™ driver assembly to tighten the set screw into the proximal hole of the plate. Insert the drill guide sleeve into the hole of the guide block and drill with the 1.9 mm drill bit. Screws may be inserted without removing the guide block.

Step 21

If non-locking screws are desired in the distal screw holes, the standard drill guide handle and center drill guide tip should be used with the 1.9 mm drill bit.

Step 22

Drill to desired depth. Take care to not move the plate after drilling for a locking hole in order to maintain the proper pilot hole alignment and prevent the screw from cross threading. For distal screws and pegs, use only the provided dual banded blue/green depth gage (DRE-059-10) to determine the required screw length.

10

Step 23

Use the appropriate Mini HEXSTAR™ driver (MXM-056T) and black handle (HCS-058) to insert a 2.0 mm fixed-angle locking peg, 2.4 mm fixed-angle locking screw, or 2.4 mm non-locking screw into the distal hole. Two finger tightening technique is recommended when inserting the screws. The guide block does not need to be removed to insert screws.

Step 24

(Optional) For the variable-angle locking screws, prior to inserting the screw, insert the Mini PEEK Ring (VAR-032-24), made from PEEK-OPTIMA™ polymer by Invibio, into the plate. Drive the Mini PEEK Ring until the ring shoulder stops at the top surface of the plate and the driver pops out of the Mini PEEK Ring. The Mini PEEK Ring driver is single use only and should be disposed of.

Note: Follow the path of the drill hole when inserting the screw so that cross threading does not occur with locking pegs and screws. Do not over tighten.

Note: A torque limiting handle (DRV-055-65) is available upon request. The handle may generate an audible or tactile “pop” when the maximum allowable torque has been achieved.

Warning: Place all distal non-locking screws before using the 2.4 mm variable-angle locking screws.

11

Step 25

For the 2.4 mm variable-angle locking screws, after the Ring is seated in the plate, use the 1.6 mm variable hex drill guide with the standard drill guide handle and drill using the 1.6 mm drill bit to the desired depth. Measure using the dual banded blue/green depth gage.

Step 26

Remove the desired 2.4 mm variable-angle locking screw from the screw caddy using the blue banded HEXSTAR™ driver (VAR-056-24H). Use the HEXSTAR driver to insert the selected screw into the hole and drive the screw. For variable-angle locking screws, stop driving the screw when the bottom of the head hits the top surface of the Mini PEEK Ring.

Note: If drilling before the Ring is inserted into the plate is preferred, the 1.6 mm cone drill guide (VAR-071-16-F) is available upon request and can be used in conjunction with the 1.6 mm drill bit. Thread the cone drill guide into the plate, drill, then insert the ring into the plate.

Note: An optional self-retaining sleeve (VAR-056-24-SR) is available upon request for the variable-angle locking driver.

For variable-angle locking screws, switch to depth-limiting driver.

12

Step 27

For the variable-angle locking screws, use the depth limiting driver (VAR-056-24) to fully seat the screws. Using the depth limiting driver, drive the screw normal to the top surface of the Mini PEEK Ring, until the driver disengages. The highest point of the screw should sit flush with the top surface of the Mini PEEK Ring.

Step 28

Repeat Steps 19–27 until the distal holes are appropriately filled.

Step 29

To drill for the screws in the proximal side of the plate, determine the type of screw to be used (3.5 mm non-locking, 3.5 mm fixed-angle locking or 3.5 mm variable-angle locking). A combination may be used. Use the 2.4 mm drill and appropriate drill guide to drill (see step 14). For 3.5 mm variable-angle locking screws reference the MAXLOCK™ EXTREME™ Variable-Angle Locking Screw Surgical Technique (MXE-801-016).

Note: Do not drive the screws too deep. Only drive the screw until the highest point of the screw is flush with the top of the Mini PEEK Ring. Do not use power instruments with the depth limiting driver.

Warning: The variable-angle screws may only be inserted into the Mini PEEK Ring once before it must be discarded.

Correct driver alignment

Incorrect driver alignment

13

Step 30

Drill to desired depth. Take care to not move the plate after drilling for a fixed-angle locking screw in order to maintain the proper pilot hole alignment and prevent the screw from cross threading. Use the provided single banded magenta depth gage to determine screw length. Use the appropriate HEXSTAR™ driver and maroon handle to insert a fixed-angle locking or non-locking screw.

Step 31

Repeat steps 29–30 as necessary until the proximal holes are filled with the desired screws. Once all the screws have been placed, alternately tighten each screw until all are fully tightened and flush with the plate implementing the standard two finger finishing technique. Take caution to not over tighten screws.

Step 32

Verify final plate and screw placement using fluoroscopy.

Step 33

Reattach the pronator muscle and fascia using absorbable suture. Replace soft tissues as required by the operative procedure and surgeon’s preferred technique. Close the incision.

General Note: Do not use other manufacturer’s instruments or implants in conjunction with the DRLOCK™ EXTREME™ System.

14

Implants & Instruments

DRLOCK™ EXTREME™ Plates

Catalog # Description

DRE-002-0L Short Left Plate

DRE-002-1L Standard Left Plate

DRE-002-0NL Short Narrow Left Plate

DRE-002-1NL Standard Narrow Left Plate

DRE-002-0R Short Right Plate

DRE-002-1R Standard Right Plate

DRE-002-0NR Short Narrow Right Plate

DRE-002-1NR Standard Narrow Right Plate

DRLOCK™ EXTREME™ Fixed-Angle Locking Peg


DRE-121-20-10 2.0 mm × 10 mm Fixed-Angle Locking Peg











15

MINI MAXLOCK™ EXTREME™ Non-Locking Screw


MXM-011-24-10 2.4 mm × 10 mm Non-Locking Screw











MINI MAXLOCK™ EXTREME™ Fixed-Angle Locking Screw


MXM-021-24-10 2.4 mm × 10 mm Fixed-Angle Locking Screw











DRLOCK™ EXTREME™ Variable-Angle Locking Screw


VAR-031-24-10 2.4 mm × 10 mm Variable-Angle Locking Screw











Instruments


VAR-032-24 Mini MAXLOCK™ EXTREME™ PEEK Ring Assembly

DRV-040-11 1.1 mm Single Diamond K-Wire

DRE-072-16 1.6 mm Drill Bit



16

MAXLOCK™ EXTREME™ Non-locking Screws


MFT-011-35-08 3.5 mm × 8 mm Non-locking Screw






MAXLOCK™ EXTREME™ Fixed-Angle Locking Screw


MFT-011-35-08 3.5 mm × 8 mm Fixed-Angle Locking Screw






Instruments


MXL-032-35 3.5 mm PEEK Ring and Drill Guide Assembly

VAR-056-24-SR2.4 mm Variable-Angle Locking Self Retaining Driver Sleeve

VAR-056-353.5 mm Variable-Angle Locking Depth Limiting Driver

VAR-056-35-R3.5 mm Variable-Angle Locking Depth Limiting Driver Replacement Tip

VAR-156-353.5 mm Variable-Angle Locking Ring Removal Tool

VAR-071-16-F1.6 mm Variable -Angle Locking Cone Drill Guide

DRV-055-65 Torque Limiting Handle

17

Variable-Angle Locking Screw













Optional

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Notes

19

Notes

1023 Cherry RoadMemphis, TN 38117800 238 7117901 867 9971www.wright.com

10801 Nesbitt Avenue SouthBloomington, MN 55437888 867 6437952 426 7600www.tornier.com

Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant 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 Wright. Contact information can be found in this document and the package insert.

™ and ® denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates. PEEK-OPTIMA and Invibio are trademarks of Invibio Ltd. ©2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved.

DRE-801-001 Rev B ECN 160833 21-Jun-2016

TORNIER DRLOCK EXTREME · proximal portion of the plate. See page 16 for catalog numbers and...

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