MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660080S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "patient who underwent orif (gamma 4) at another hospital on (b)(6) 2025.At an unknown time, the lag screw cut out the femoral head.On (b)(6) 2025, gamma4 was removed and bha was performed.Preoperative x-rays confirmed that the blade of the u-lag screw was significantly bent.After removal, re-examination of the implant confirmed that, as seen on x-ray, the blade was significantly bent.".
Event or Problem Description
As reported: "patient who underwent orif (gamma 4) at another hospital on (b)(6) 2025.At an unknown time, the lag screw cut out the femoral head.On (b)(6) 2025, gamma4 was removed and bha was performed.Preoperative x-rays confirmed that the blade of the u-lag screw was significantly bent.After removal, re-examination of the implant confirmed that, as seen on x-ray, the blade was significantly bent.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the u-blade lag screw was received with one of the legs of the u-blade significantly bent outwards, away from the lot in the lag screw.The outer surface of the both the legs shows sever scuff marks, indicating an interaction with the surrounding bone.In the lag screw, one of the slots, apparently where the deformed u-blade was seated was found to be deformed indicating some struggle during the formation of the leg of the u-blade.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indication of material, manufacturing or design related problems were found during the investigation.For the single pre-revision x-ray, a clinical opinion was requested on the confirmation of cut-out and possibility of u-blade bending under ins influence, to which the hcp confirmed the cut-out but without any post-op and progressive x-rays after that it is difficult to conclude if cut-out was the sole reason in the bending of the u-blade.The exact cause of the cut-out could also not be determined.The available information, indicated towards bending of the u-blade due to the cut-out of the lag screw, but a confirmation of it is not possible due to lack of sufficient patient medical records.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X80MM
• 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: 23404908
• Report Number: 0008031020-2025-01997
• Device Sequence Number: 4916659
• Product Code: HSB
• UDI-Device Identifier: 07613327591729
• UDI-Public: (01)07613327591729(17)341130(10)K0FA13B
• 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): 01/15/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81660080S
• Device Lot Number: K0FA13B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: 85 YR
• Patient Sex: Female
• Patient Weight: 38 KG