MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D10X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391036S
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "nail break prior to osteosynthesis.Replaced with synthes rfna and ria".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "nail break prior to osteosynthesis.Replaced with synthes rfna and ria".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The returned nail exhibits breakage on the proximal side, located just below the oblong hole.Evidence of missdrilling is observed at both the oblong hole and the distal static hole, confirmed by shiny surfaces resulting from drill contact with the internal walls of the nail, which led to localized wall deformation.Microscopic examination indicates a mixed mode of breakage, characterized by fatigue crack initiation followed by subsequent brittle failure.Features consistent with this failure mechanism include visible fatigue lines of rest and flat, shiny fracture surfaces.These observations indicate progressive crack propagation under cyclic loading conditions, ultimately resulting in instantaneous fracture on the opposing side.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 above investigation breakage could be termed fatigue in nature and no product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the implant failure no conclusive statement can be provided, because key clinical information (e.G.X-rays in different planes, clinical status, patient activity, assessment of the treating physician or operation reports) is missing.The root causes in such cases are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and/or the device in relation to cause of the failure.If more information is provided, the case will be reassessed.

• Brand Name: T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D10X360MM
• 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: 23535810
• Report Number: 0008031020-2025-02068
• Device Sequence Number: 10202534
• Product Code: HSB
• UDI-Device Identifier: 07613327292510
• UDI-Public: (01)07613327292510(17)350131(10)K10497F
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K250163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 23391036S
• Device Lot Number: K10497F
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 118 KG