MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LAG SCREW D10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600095S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient underwent orif (gamma 4) for a right femoral transverse fracture about 2 months ago.On (b)(6) 2025, at post-operative follow-up, it was confirmed by x-ray that the lag screw had become dislodged.On (b)(6) 2025, a reoperation was performed.The dislodged lag screw was removed, replaced with artificial bone, and a new lag screw was inserted.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: GAMMA4 - LAG SCREW D10.5X95MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 23465221
• Report Number: 0008031020-2025-02038
• Device Sequence Number: 18672402
• Product Code: HSB
• UDI-Device Identifier: 07613327511017
• UDI-Public: 07613327511017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: Lay User/Patient
• Device Catalogue Number: 81600095S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male