MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251200S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "approximately 6 weeks after implantation, the gamma3 nail broke.Patient required revision surgery.".
Event or Problem Description
As reported: "approximately 6 weeks after implantation, the gamma3 nail broke.Patient required revision surgery.".
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.Both parts have been returned.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 anterior 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 anterior portion of the lag screw hole.Signs of a secondary sudden "catastrophic" brittle fracture were observed on the posterior side of the device.Evidence of misdrilling is visible on both the anterior and posterior sides of the lag screw hole.This misaligned drilling and lag screw insertion created a chamfer like edge on both sides of the hole, weakening the construct.It must be noted, nonetheless, that fatigue was the main cause of the implant's failure.The misdrilling most probably 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.This statement is confirmed by the damage observed on the shaft of the lag screw.It was not possible to determine the exact cause of the fatigue fracture.More detailed information, such as patient's medical records as well as x-ray images would have been necessary for a complete investigation.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.

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM 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 GMBH; 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: 24369558
• Report Number: 0008031020-2026-00175
• Device Sequence Number: 13206909
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 31251200S
• Device Lot Number: K1D355D
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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