MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D10X340MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: patient with gamma4 implant.The patient fell and re-fractured the femur, requiring reoperation.The gamma4 was also broken.The reoperation used an implant from another company.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned nail could be confirmed based on the catalog and the lot numbers marked.The nail broke at the lag screw hole in two parts.Only the proximal part has been returned for investigation.Evidence of fatigue could be seen on the surface of the breakage.This can be stated based on the lines of rest clearly visible on the posterior side of the nail, which are a classic indication of a fatigue fracture.According to the observations made, the fatigue fracture had its origination in the lateral side of the posterior portion of the lag screw hole.Signs of a sudden "catastrophic" brittle fracture were observed on both sides of the device, and can be linked to high-intensity trauma.The observations made correspond to the information received, that the implant failure was noticed after the patient fell.It must be noted, nonetheless, that the fatigue fracture was the main cause of the implant's failure.The patient's fall accelerated the breakage of an already weakened nail.Material deformation (bearing points) can be observed on the edge of the lag screw hole.This indicates that the nail was subjected to severe loads, leading to displacement of the lag screw, associated with the breakage of the nail.Based on investigation, the root cause was attributed to a patient related issues.The nail breakage occurred due to a combination of fatigue and the patient's fall.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: patient with gamma4 implant.The patient fell and re-fractured the femur, requiring reoperation.The gamma4 was also broken.The reoperation used an implant from another company.".

• Brand Name: GAMMA4 - LONG NAIL, LEFT D10X340MM 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: 23053528
• Report Number: 0008031020-2025-01530
• Device Sequence Number: 20977938
• Product Code: HSB
• UDI-Device Identifier: 07613327474480
• UDI-Public: (01)07613327474480(17)340430(10)K1B5654
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 85250340S
• Device Lot Number: K1B5654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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 Sex: Unknown