MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - LAG SCREWDRIVER 380X110MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200200
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "instrument no longer ¿grips¿ the femoral neck screw.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d4 lot # and h6 device code.The reported event could not be confirmed since the device was not returned for evaluation to verify the alleged failure.The returned device underwent visual inspection, which revealed deformation on the proximal side of the threaded rod.The rod appeared slightly bent, with areas where the material was pressed inward.Additionally, the teeth exhibited noticeable deformation and were displaced from their original geometry, indicating that the material had been pressed outward and distorted from its intended shape.Functional inspection was performed using a sample lag screw.It was observed that the lag screw could not be locked in place on the side where deformation was present.Additionally, the engagement point for the teeth could not secure the lag screw without the threaded rod, as the deformation of the teeth interfered with proper locking.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material-, manufacturing-, or design-related problems were found during the investigation.Based on the findings from the investigation, the root cause is attributed to user-related factors.The deformation observed on both the teeth and the threaded rod suggests damage consistent with metal-to-metal contact under force, indicating improper handling or use during the procedure.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "instrument no longer ¿grips¿ the femoral neck screw.".

• Brand Name: GAMMA3 - LAG SCREWDRIVER 380X110MM
• 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: 23839713
• Report Number: 0008031020-2025-02188
• Device Sequence Number: 18534762
• Product Code: LXH
• UDI-Device Identifier: 04546540377807
• UDI-Public: (01)04546540377807(10)K132DA1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 13200200
• Device Lot Number: K126F81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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