MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D12X320MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391232S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	05/22/2025
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
As reported: "primary surgery was performed on (b)(6) 2023.The nail broke in the third week of (b)(6) 2025 and was removed on (b)(6) 22.".
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2023.The nail broke in the third week of may 2025 and was removed on (b)(6)." additional information: before the nail fracture, there was some discomfort when walking.Thereafter, there was a strange noise and pain when walking, but at the patient's own discretion, after about two weeks of observation, he went to see the doctor, and the nail fracture was discovered.
Additional Manufacturer Narrative
Please note the correction to b5 and d4 lot #.The reported event could be confirmed since the device was returned for evaluation and could be traced back to the alleged event.The returned nail is broken into two fragments from the oblong hole.On both fragments, we can see lines of rest at the microscopic level, which indicate fatigue failure since no plastic deformation is visible.The incipient crack started at the smallest cross section on the lateral side of the anterior web and progressed toward the medial side.The shiny surface on the anterior side suggests rubbing of the fragments together before splitting into two after fatigue failure, causing them to break in a brittle manner.The available radiograph medical opinion was sought: non-union is visible in the available radiograph, which led to the breakage of implant more than 2 years after implantation.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.The instruction of use clearly states that:- ¿the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.¿ original statements.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation definitive root cause cannot be given with the available product.The breakage is caused in a fatigue manner, and with a radiograph, non-union is visible.The exact root cause cannot be defined as non-unions are, in general, multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implants.If more information is provided, the case will be reassessed.If further information is provided, the investigation report will be reassessed.

• Brand Name: T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D12X320MM
• 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: 22285181
• Report Number: 0008031020-2025-00973
• Device Sequence Number: 12992346
• Product Code: HSB
• UDI-Device Identifier: 07613327293005
• UDI-Public: (01)07613327293005(11)220202(17)320131(10)K0B435B
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 23391232S
• Device Lot Number: K0B435B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: Male