MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D10X380MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34250380S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2025
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
It was reported that a gamma 3 nail fractured which resulted in a revision operation.
Event or Problem Description
It was reported that a gamma 3 nail fractured which resulted in a revision operation.
Additional Manufacturer Narrative
Please note the correction to d5 and h6 device code.The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received nail is completely broken in the webs of the proximal lag screw hole.On the proximal side, instantaneous breakage can be seen at medial end.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.Slight drill marks and deformation were found at the lateral entrance.The drill marks were most likely caused by misdrilling which created the starting point of the fracture.On the distal side, heavy material deformation can be seen which most likely had contributed to the starting point of the fracture at lateral.The lag screw bearing point shows strong impression marks and deformation from high compressive load, indicating the nail was exposed to continuous high load over a longer period.Therefore, the breakage pattern resembles a fatigue breakage of the nail.The breakage was most likely initiated in a fatigue manner due to initial misdrilling and broke instantaneously from the other side due to high tension and loading over time.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.Based on the investigation, the breakage of the implant happened in a fatigue manner by application of continuous high load overtime, further medical records and radiographs are required to know the exact root cause for the breakage of the nail.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D10X380MM 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: 22750922
• Report Number: 0008031020-2025-01339
• Device Sequence Number: 12911161
• Product Code: HSB
• UDI-Device Identifier: 04546540375360
• UDI-Public: (01)04546540375360(17)290930(10)K1E085C
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• 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): 12/17/2025

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: 34250380S
• Device Lot Number: K1E085C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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