MAUDE Adverse Event Report: STRYKER GMBH T2 FEMUR - FEMORAL NAIL, A/R, R1500 D11X440 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18281144S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "imn retro femur was done on (b)(6) 2025.The doctor saw the patient in the clinic on (b)(6) 2026 and reported that the a/r nail in this patient was bending".
Event or Problem Description
As reported: "imn retro femur was done on (b)(6) 2025.The doctor saw the patient in the clinic on (b)(6) 2026 and reported that the a/r nail in this patient was bending".
Additional Manufacturer Narrative
The reported event could be confirmed with the provided x-ray images, in which we can see that the nail is slightly bent.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Hcp opinion on provided x rays: "the non-union led to the bending and the nail seems to be of too small diameter.But the information is very limited, and we only have these two x-rays." based on the limited information available, the root cause of the reported event cannot be defined, as this is often multi-factorial: the location of the fracture and the technical aspects of the surgical procedure could have contributed to the event.Furthermore, the patient¿s condition and activity levels post-op may also have contributed to inadequate load distribution and, therefore, the bending of the implant.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 FEMUR - FEMORAL NAIL, A/R, R1500 D11X440 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 GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24682582
• Report Number: 0008031020-2026-00465
• Device Sequence Number: 10014516
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K081152
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 18281144S
• Device Lot Number: K0DBF38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2021
• 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: Other
• Patient Age: 19 YR
• Patient Sex: Unknown