MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81250170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 received nail overall was found without any significant damage, except for screw interaction marks inside the respective holes and deformation along the medial edge.This deformation along the medial edge is indicative of the fact that there was some movement, either of the lag screw or the u-blade which led to these marks.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 - TROCHANTERIC NAIL 170MM D10X170MM X 125DEG
• 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: 23404907
• Report Number: 0008031020-2025-01996
• Device Sequence Number: 17372529
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: (01)07613327479058(17)350228(10)K114F71
• 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 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: 81250170S
• Device Lot Number: K114F71
• 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: 03/19/2025
• 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
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 38 KG