stryker Rayhack Ulnar Shortening Generation II Instruction Manual

This publication sets forth detailed recommended procedures for using Stryker devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.

Important

• The patient should be advised that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity or trauma and that the device has a finite expected service life.
• Removal or revision of the device may be required sometime in the future.
• Cleaning and sterilization information is provided in the applicable instructions for use.
• Non-sterile devices, including implants and instruments, must be cleaned and sterilized prior to use, in accordance with validated methods.
• Devices that are able to be disassembled should be disassembled prior to point-of-use processing. Additionally, devices with movable components that do not facilitate disassembly should be manually articulated during the point-of-use processing step in order to evacuate additional soils.
• Please remember that the compatibility of different product systems has not been tested unless specified otherwise in the product labeling.
• Consult Instructions for Use (https://ifu.wright.com) for a complete list of potential adverse effects and adverse events, contraindications, warnings and precautions.
• The surgeon must advise patients of surgical risks, and make them aware of adverse effects and alternative treatments.
• An implant whose packaging is open or damaged or whose expiration date has passed must not be used. Every precaution must be taken to ensure sterility when opening the packaging of the implant and during implantation.

Indications

The Rayhack Ulnar Shortening System is intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.

Contraindications

There are no device specific contraindications associated with this system.

Product information

Options available

In addition to this low-profile plate, the surgeon has the option of using the Generation I non-locking plate.

Plate placement

Ulnar subcutaneous surface (technically easier). Volar ulnar surface.

Saw guide

Generation I saw guide (ulnar subcutaneous approach).  Universal surface-mount saw guide (both approaches).

Titanium plate

Only available in Rayhack Generation I non-locking design.

Operative technique

Rayhack Ulnar Shortening

Generation II Low-Profile Locking System

Step 1 – Placement of the universal surface-mount ulnar saw guide

Options

1. Volar ulnar surface
2. Subcutaneous ulnar surface

Volar ulnar surface

A 10cm incision is made along the ulnar subcutaneous border. The FCU tendon and surrounding soft tissues are retracted anteriorly.

The Generation I saw guide cannot be used for volar application. | Figure 1

Subcutaneous ulnar surface

Utilizing the same skin incision, the interval between the FCU and ECU is developed and the ulna is exposed. The Generation I saw guide or the Generation II Figure 2 surface-mount saw guide may be used.

Step 2 – Positioning of the straight drill guide and fixation of the saw guide

In order to prevent excessive distal placement of the shorter Generation II saw guide, it is critical to first apply the plate on the ulnar surface so the distal plate end is approximately 3cm from the distal ulnar surface. Contouring the ulnar plate during the first stage is an option (see STEP 5). Mark hole #2 on the bone. Manually hold the saw guide centered on the ulna, line up screw hole #2 of the saw guide with the location of the mark on the ulna. Apply the straight drill guide and drill hole #2 with a 2.5mm drill bit. | Figure 3 Measure, tap and insert a 3.5mm cortical screw. Keep the saw guide centered on the ulna, repeat the process for screw hole #4 and then #3.

Note:

In Generation II, only holes #2, #3, and #4 will be drilled. Hole #1 will be drilled through the doublethreaded drill bushing for placement of the 2.7mm locking screw.

Note:

Surgeons utilizing the Generation I saw guide who are placing a Generation II lowprofile locking ulnar shortening plate on the ulnar  subcutaneous border must remember to avoid drilling hole #1 as this will be the site of the future 2.7mm  locking screw. | Figure 4

Step 3 – Width of the ulnar osteotomy and anticipated linear shortening  of 3.5, 4.9, or 7.4mm

The stated distances between the slots are measured perpendicular to the osteotomy surfaces and represent the actual machined distances in the saw guide. The anticipated linear shortening of the bone: calculated as the hypotenuse of the right triangle is this perpendicular measurement multiplied by the square root of 2: (1.4142). Due to various clinical factors (amount of plate prebending, use of the specified saw blade, degree of linear compression, etc.) the actual amount of bone shortening will be very close to the hypotenuse in length. | Figures 5 and 6

Step 4 – Performing the oblique ulnar shortening osteotomy

Use either of the dedicated saw blades designed for theulnar osteotomy and make the distal cut first. Irrigate with sterile slush saline to minimize thermal necrosis.

Use a gentle side-to-side motion with a pencil grip sagittal saw. | Figure 7

Complete the proximal osteotomy cut and remove the intervening bone fragment. | Figure 8

Carefully remove the three cortical screws and place them in the temporary holding slots.

Self-tapping screws are not advised as reinsertion of screws may cut a new thread in the bone and lead to screw loosening.

Step 5 – Low-profile locking ulnar bone plate fixation

Pre-bend the ulnar plate to the ulnar contour prior to applying to the bone. This is especially important when placing on the ulnar subcutaneous border. In this location, the plate will be bent convex toward the surgeon. In the volar approach, the distal plate end may need to be contoured. Pre-bending the plate during the first stage of plate placement is an option. | Figure 9

Insert the previously inserted screw #2 into hole #2 of the low-profile locking plate. (Or hole #2 of the Generation I non-locking ulnar plate.) | Figure 10

Step 6 – Application of the compression device

Apply the low-profile compression device over the plate and screw hole #3. Insert a 3.5mm cortical screw through hole #3 that is 4mm longer than the original screw. This screw may be tightened to secure the plate and fixed block. | **Figure 11

**

Apply a screw through the sliding block, the oblong slot in the plate and hole

4. It is important to keep this screw slightly loose during the osteotomy

compression. | **Figure 12

Step 7 – Compression of the osteotomy**

Gently and evenly compress the osteotomy with a 2.5mm hex screwdriver alternating between both horizontal compression screws. | Figure 13

DO NOT utilize only one screw to compress the osteotomy as this may eccentrically load and damage the compression device and horizontal compression screws.

Do not excessively compress the osteotomy. Stop compression when both surfaces are visually compressed. | Figure 14

Step 8 – Drilling the 22 degree interfragmentary lag screw hole

Apply the 22 degree angled drill guide into the round hole of the fixed block. | Figure 15A

Drill the first cortex with a 2.7mm drill bit. (Avoid drilling two cortices.) | Figure 15B

Apply the 2.7mm smooth drill bushing into the angled drill guide. | Figure 15C

Drill a 2.0mm hole in the far cortex through the smooth drill bushing. | Figure 15D

In some osteotomies employing slots 1 and 3 of the saw guide, the angled drill guide will not seat between the two blocks of the compression device. This occurs due to the morphology of the ulna or excessive compression of the osteotomy. In this instance, freehand the 2.7mm drill bit hole at the desired angle for the interfragmentary lag  screw, then proceed with inserting the drill bushing and drilling the 2.0mm hole.

Step 9 – Oblique 2.7mm interfragmentary lag screw application

Remove the 22 degree angled drill guide. | Figure 16

Measure the interfragmentary screw hole depth. | Figure 17

Reapply the angled drill guide and tap the far cortex with a 2.7mm tap. | Figure 18

Carefully insert the 2.7mm cortical lag screw. | Figure 19

Step 10 – Final fixation of the plate – screw #5 and the locking screw application

Using the handheld drill guide, drill hole #5 with a 2.5mm drill bit. Measure, tap and then insert a 3.5mm cortical screw. | Figure 20

Gently screw in either end of the double-threaded drill bushing into hole #6. | Figure 21

Drill a 2.3mm hole through both cortices. Unscrew the threaded drill bushing. | Figure 22

Measure and carefully insert a 2.7mm self-tapping locking screw with the star 8 driver. | Figure 23

Repeat the process for screw #1. | Figure 24 Gently insert the 2.7mm locking screw into hole #1. Do not over-tighten. | Figure 25

Remove the compression device and insert the original 3.5mm screws #3 and #4.

Step 11 – Ulnar shortening 9.1 – 18.1mm

Occasionally an ulna may be excessively long and require an osteotomy in excess of 7.4mm. It is possible to use the Rayhack Ulnar System to perform this osteotomy. This requires slightly more time and continued strict adherence to specific details. As the osteotomy width becomes larger, the technical demands of approximating the osteotomy may become even greater with the excessive tension exerted by the soft tissues attached to the distal fragment. Use of the compression device to approximate the osteotomy is particularly helpful in this regard.

The stated distances between the slots are measured perpendicular to the osteotomy surfaces and represent the actual machined distances in the saw guide. The anticipated linear shortening of the bone calculated as the hypotenuse of the right triangle is this perpendicular measurement times the square root of 2: (1.4142). Due  to various clinical factors (the amount of plate prebending, use of the specified saw blade, degree of linear compression) the actual amount of ulnar shortening will vary slightly but will closely approach the calculated hypotenuse. | Figure 26

Osteotomy width (Perpendicular to osteotomy)| Anticipated shortening
---|---
F: 6.4mm| 6: 9.1mm
G: 8.3mm| 7: 11.7mm
H: 10.1mm| 8: 14.2mm
I: 11.0mm| 9: 15.5mm
J: 12.8mm| 10: 18.1mm

Step 12 – Ulnar shortening 9.1 – 18.1mm – shifting  the saw guide distally

Volar option (not recommended)

Subcutaneous option (recommended)

Apply the Generation I (4-hole) ulnar saw guide. | Figure 27 Drill and insert the 3.5mm cortical screws

into holes 2 and 3 of the saw guide. The screws are removed and placed in the tray’s holding slots. The saw guide is shifted one hole distally and screws #2 and #3 are inserted through saw guide holes #1 and #2 respectively. | Figure 28 Hole #4 is drilled, tapped, and a cortical screw is inserted. The distal osteotomy cut is made.

Step 13 – Ulnar shortening 9.1 – 18.1mm – shifting the saw guide proximally

D | Remove the saw guide and place the screws in the temporary tray holding slots.

E | Shift the saw guide back to its original position and reapply screws #2 and #3. | Figure 29 Cut in the proximal slot according to the desired amount of ulnar shortening.

F | Remove the saw guide and replace the screws in the corresponding tray slots.

G | Apply the plate and insert screw #2. Apply the compression device and apply the longer temporary 3.5mm cortical screws through holes #3 and #4. | Figure 30

It may be necessary to grasp the distal ulna with a towel clip to pull it proximally in attempting to insert screw #4. If this is unsuccessful, drill an additional hole 3mm more proximally in line with the previous hole #4. Compress the osteotomy as per the standard osteotomy routine depicted in Step 7.

Step 14 – Intraoperative x-rays

To visualize the osteotomy surface, it is advisable to obtain two X-rays: one AP forearm in supination or 30 degrees short of full supination and one PA forearm in pronation. This will usually permit a true frontal and lateral view of the plate and osteotomy. Any screws deemed to be excessively long or too short may be replaced.

Step 15 – Post-operative care – plate breakage warning

In most cases a volar and dorsal plaster splint can be used to immobilize the forearm until the sutures are removed at two weeks post surgery. Most patients can be placed in a short arm removable plastic splint and protected until bone healing has occurred. In non-compliant patients, it is recommended that a sugar tong splint be applied at surgery and a short or long arm cast applied at the two week follow-up appointment. This can be converted to a thermoplastic splint when the surgeon is convinced that healing is satisfactory. No activity against resistance is permitted until bone healing has occurred.

Caution:

Plate breakage can occur if the patient remains unprotected prior to bone healing . In case of delayed union or non-union appropriate corrective measures must be taken to avoid plate breakage and loss of bone fixation.

Delayed union

A delayed union may occur on occasion. As long as no screw “toggle” or “backing out” occurs, the osteotomy will usually heal if adequately protected. If excessive callus appears or if any longitudinal plate bending occurs, or if screw loosening is noted, additional extended protection of the extremity or surgical intervention with  replating and/or bone grafting may be necessary.

Implant removal

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.

Appendix

Rayhack Ulnar Shortening Generation II

Low-Profile Locking System

Instrumentation

Rayhack Ulnar Shortening Generation II

Low-Profile Locking System

Saw blade summary

Two individually packaged sterile saw blades are provided with each Rayhack Ulnar and Kienbock system. Both saw blades 40100110 and 110 are compatible with the Linvatec/Hall/MicroAire saws. Part numbers 40100410 and 410 saw blades are compatible with Stryker saws.

The provided saw blades are specifically designed for use with the Rayhack Ulnar and Kienbock systems. Using a generic blade is considered off-label and the responsibility of the user.

The below chart is for reference only. Due to manufacturer’s specification changes, Stryker cannot guarantee the saw blades will fit all system

| | Stryker part no.| Pneumatic| Electric| Battery
---|---|---|---|---|---
| | | 1000-100/1950| 1000ET/1950| 6642B/6672
| | | 1000-100/1955| 000ET/1955| 6642B/6670 (Battery SmartDriver)
| | | | 1641/6672 (Electric SmartDriver)|
Hall (Linvatec)

Microaire and Hall (Linvatec) compatible

| ZS110*| 40100110 110| 5053-011 Micro 100| 6020-022 Micropower (Pencil Style)| Pro6200/Pro2043 Mpower
| | Pro6150/Pro2043 Pneumatic PowerPro| 6021-022 Micropower (Pencil Style)| Pro6200/Pro2043 Mpower
| | | 5020-022 Microchoice (Pencil Style)| Pro5100/Pro2043 Powerpro
| | | Pro6100/Pro2043 (Electric Powerpro)| Pro5100/Pro2043 Powerpro
Stryker

Stryker compatible

| SP440 R*| 40100410 410| | Command II 2296-34| Cordless Driver 4200 with 4100-400 Saw
 |  |  | TPS 5100-34|
| |  | Core 5400-34|
| | | 5400-99/4100-400 (Core Driver with Saw)|

Note:

Right angle grip of battery drivers is more difficult to use compared to pencil type grips.

*Microaire part no.

Ordering information

Rayhack Ulnar Shortening Generation II

Low-Profile Locking System

Rayhack Ulnar Shortening Generation II

Low-Profile Locking System

*4009 KITA/1 US distribution only

References

1. Rayhack, JM, Technique of Ulnar Shortening. Techniques in Hand and Upper Extremity Surgery. Vol. II (1): 57-65, 2007.
2. Rayhack, JM, Ulna Shortening for Impaction Syndrome In; Master Techniques in Orthopaedic Surgery: The Wrist, 3rd edition, edited by Gelberman RH (2009).
3. Rayhack, JM, “Ulnar Carpal Abutment – Ulnar Shortening Osteotomy” In; The Wrist: Diagnosis and Operative Treatment Second Edition, Second Edition, Cooney WP (2009).
4. Rayhack, JM, Open Ulnar Shortening for Ulnocarpal Impaction In; Principles and Practice of Wrist Surgery.” Slutsky D (2009).

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate a Stryker product. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

The instructions for use, operative techniques, cleaning instructions, patient information leaflets and other associated labeling may be requested online at ifu.wright.com or wright.com. If saving the instructions for use, operative techniques, cleaning instructions from the above mentioned websites, please make sure you always have the most up to date version prior to use.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Rayhack, Stryker, Tornier, Wright Medical Technology. All other trademarks are trademarks of their respective owners or holders.

Microaire is a registered trademark of Microaire Surgical Instruments LLC Content ID: 009162C_11-09-2021 Copyright © 2021 Stryker

Manufactured by:

Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117
161 Rue Lavoisier
38330 Montbonnot Saint Martin
France
stryker.com

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