MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GAMMA4 - LONG NAIL, LEFT D11X440MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85251440S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gamma 4 nail fractured at the proximal body near the lag screw junction approximately six months following implantation.The patient underwent a revision procedure, during which the fractured nail was extracted and replaced with a new nail.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event was not confirmed since the device was not returned for evaluation and no other evidences were provided.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a gamma 4 nail fractured at the proximal body near the lag screw junction approximately six months following implantation.The patient underwent a revision procedure, during which the fractured nail was extracted and replaced with a new nail.

• Brand Name: GAMMA4 - LONG NAIL, LEFT D11X440MM X 125DEG
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 23215423
• Report Number: 0009610622-2025-00017
• Device Sequence Number: 8791287
• Product Code: HSB
• UDI-Device Identifier: 07613327474756
• UDI-Public: (01)07613327474756(17)341031(10)K1E57B6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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?: Yes
• Device Catalogue Number: 85251440S
• Device Lot Number: K1E57B6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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 Sex: Unknown