MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965050S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2025
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: "patient was implanted with a 9mm 380mm t2 femoral nail which very recently failed with fractured distal locking screws and fractured proximal portion of nail, broken implant was removed and revised with a 11mm 360mm t2 alpha nail.".
Event or Problem Description
As reported: "patient was implanted with a 9mm 380mm t2 femoral nail which very recently failed with fractured distal locking screws and fractured proximal portion of nail, broken implant was removed and revised with a 11mm 360mm t2 alpha nail.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received screws were visually examined, and it was observed that one screw was broken in the middle.The other screw, measuring 55mm in length, was found to be in acceptable condition, with slight deformation on the crest of the threads and visible nick marks.The fracture surface of the broken screw was examined under a microscope, and the fracture surface indicated a combination of fatigue and brittle fracture, as no plastic deformation was visible.We observe a brittle fracture at the end of the screw, which suggests a sudden breakage at that point.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 over time.The exact root cause cannot be defined without the proper medical documents like post operative radiographs.If any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X50 MM
• 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: 23253722
• Report Number: 0008031020-2025-01678
• Device Sequence Number: 18752196
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: (01)04546540202512(17)291031(10)K1E74E2
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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: 18965050S
• Device Lot Number: K1E74E2
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: 60 YR
• Patient Sex: Female