MAUDE Adverse Event Report: Stryker GmbH GAMMA4 - LAG SCREW REAMER; Orthopedic Manual Surgical Instrument

Catalog Number	14200240
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales rep reported that when in use, the reamer oscillates abnormally.Additional information received: the procedure was completed, but the operating time was extended.This had an impact on the patient, as the drill bit rubbed against the nail, causing titanium debris to enter the patient¿s body.Two motors were used to verify that the problem was not with the drill chuck, but the issue persisted.For the patient, there was an increased risk of infection due to the longer procedure time and more frequent entries and exits from the operating room.Increased sterilization volume, longer operating room occupancy.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: GAMMA4 - LAG SCREW REAMER
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Trauma GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25548587
• Report Number: 0008031020-2026-00776
• Device Sequence Number: 10751709
• Product Code: LXH
• UDI-Device Identifier: 07613327510133
• UDI-Public: 07613327510133
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 14200240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown