MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - K-WIRE D3.2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	12106450
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "when rotating the nail to adjust its position during insertion of the guide pin for the lag screw, the guide was rotated without being fully removed, and then rotated again with the handpiece, causing the guide pin to shear off.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on investigation, the root cause was attributed to a user related issue.As mentioned in the reported event, the user was rotating the devices while the k-wire was not fully removed, therefore leading to the breakage of its tip.In this relation, the operative technique indicates the following: k-wire placement: the target device may be held by an assistant to prevent its weight from externally rotating the nail until the next stage is completed.Check the proper k-wire position with the image intensifier in both the anterior, posterior and mediolateral views to ensure that k-wire deflection did not occur.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when rotating the nail to adjust its position during insertion of the guide pin for the lag screw, the guide was rotated without being fully removed, and then rotated again with the handpiece, causing the guide pin to shear off.".

• Brand Name: GAMMA3 - K-WIRE D3.2X450 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23222589
• Report Number: 0008031020-2025-01672
• Device Sequence Number: 15830106
• Product Code: LXH
• UDI-Device Identifier: 04546540175359
• UDI-Public: 04546540175359
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 12106450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown