MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the femoral head was penetrated with the lag screw postoperatively.During the initial surgery, also a penetration of the femoral head occurred, necessitating replacement of the implant.The surgeon considers that the recurrence of femoral head penetration postoperatively was caused by this effect." this record covers the post-operative lag screw perforation.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation, but medical record like radiographs, are required to confirm.Visual inspection of the returned devices showed significant damage on the nail near the end-cap insertion area, with deformation patterns that could be consistent with forces applied during explantation.Misdrilling marks were noted around the oblong hole at the distal end of the nail.The pre-inserted set screw displayed a shiny surface at its tip, indicating engagement within the lag screw groove, which is further supported by corresponding shiny wear marks on the lag screw itself.Two distinct shiny areas on the lag screw groove suggest that the lag screw may have experienced slight loosening during use.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.The operative technique states that: "after tightening the set screw, unscrew the set screw by no more than a quarter (1/4) of a turn, until a small amount of rotation can be felt at the lag screw driver.This ensures controlled subsidence of the proximal fragment while still preventing medial migration of the lag screw." no indications of material, manufacturing or design related problems were found during the investigation.Based on the findings from the investigation, evidence of set screw engagement and subsequent loosening was observed; however, without supporting intraoperative or postoperative radiographs, the reported event cannot be confirmed.A probable contributing factor may be loosening of the set screw beyond the specified quarter-turn.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the femoral head was penetrated with the lag screw postoperatively.During the initial surgery, also a penetration of the femoral head occurred, necessitating replacement of the implant.The surgeon considers that the recurrence of femoral head penetration postoperatively was caused by this effect." this record covers the post-operative lag screw perforation.

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X90MM
• 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: 23922211
• Report Number: 0008031020-2025-02310
• Device Sequence Number: 13015022
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: (01)07613327591804(17)350831(10)K1495D2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: Lay User/Patient
• Device Catalogue Number: 81660090S
• Device Lot Number: K1495D2
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2025
• 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; Other
• Patient Sex: Unknown