MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D10X300MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250300S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the orif was performed on (b)(6) 2024 due to left femoral trochanteric fracture.On (b)(6) 2025, the sales rep was consulted by the doctor about the patient's broken nail.Breakage of the nail in lug position was confirmed.The revision surgery to remove the broken nail will be performed on (b)(6) 2025.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but the x-rays confirmed the alleged breakage.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A few post-op and post failure x-rays were shared for evaluation.These were presented to our hcp whose opinion was that the reduction was not adequate enough.The dislocation/gap between the proximal and distal part is still significant, the fracture parts do not really seem to touch or be close to each other.Therefore, this suggest that reason is non-union since, after a year, we see little callus bridging, which is related to the gap, which was too big.Based on the x-ray evaluation, the breakage of the nail most likely happened due to the non-union, but more information, as well as the affected device, must be available in order to determine the exact root cause of the issue.If the device is returned, or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the orif was performed on (b)(6) 2024 due to left femoral trochanteric fracture.On (b)(6) 2025, the sales rep was consulted by the doctor about the patient's broken nail.Breakage of the nail in lug position was confirmed.The revision surgery to remove the broken nail will be performed on (b)(6) 2025.".

• Brand Name: GAMMA4 - LONG NAIL, LEFT D10X300MM 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 GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23299567
• Report Number: 0008031020-2025-01782
• Device Sequence Number: 18637055
• Product Code: HSB
• UDI-Device Identifier: 07613327474725
• UDI-Public: (01)07613327474725(17)340331(10)K1AE689
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 85250300S
• Device Lot Number: K1AE689
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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: 70 YR
• Patient Sex: Male