MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, RIGHT D10X320MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84250320S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that "during insertion of a gamma 4 long nail for a subtrochanteric femoral fracture, the nail tip perforated the anterior aspect of the femur at the upper femoral condyle.The entry was repositioned anteriorly and the nail was reinserted deeply.The surgery was completed.The device is implanted in the patient's body".
Event or Problem Description
It was reported that "during insertion of a gamma 4 long nail for a subtrochanteric femoral fracture, the nail tip perforated the anterior aspect of the femur at the upper femoral condyle.The entry was repositioned anteriorly and the nail was reinserted deeply.The surgery was completed.The device is implanted in the patient's body".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned, and no other evidence was shared for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.No indication of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected devices must be available in order to determine the exact root cause of the issue.The operative technique clearly provides warning: care must be taken with reamers for the intramedullary canal.Ensure that: -the guide wire with the ball tip is used -the guide wire is correctly positioned (not advanced into the knee joint) -the guide wire is not displaced laterally during reaming (could lead to an offset position for the nail and a higher risk of an iatrogenic fracture).If the device is received or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - LONG NAIL, RIGHT D10X320MM 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: 23783832
• Report Number: 0008031020-2025-02151
• Device Sequence Number: 10374588
• Product Code: HSB
• UDI-Device Identifier: 07613327479515
• UDI-Public: (01)07613327479515(17)350131(10)K10D9ED
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 84250320S
• Device Lot Number: K10D9ED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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: Other
• Patient Sex: Female