MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D11X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391136S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/14/2025
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: "distal femur orif performed with single construct t2 alpha retrograde nail and interlocking 5mm screws and a blocking screw near the break site.An oblique interlocking screw was removed due to backout prominence and then at a later date the nail went on to breakage at the 6th hole of the distal cluster of interlocking screws.The surgeon and residents removed the nail and performed a ria and nail replacement using the synthes rfna retrograde femur nailing system advanced.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received nail was broken at the level of the last proximal round hole.The breakage surface initially appears relatively smooth, transitioning into a rough, granular region toward the end.No visible plastic deformation is present on either end of the nail, indicating that the failure occurred in a brittle manner.Additionally, the presence of lines of rest suggests that the breakage initiated as a fatigue-driven process, eventually culminating in a sudden breakage in a brittle manner.This is further supported by the shiny region observed on the medial side of the nail, characteristic of rapid final failure.With an available radiograph, a formal medical opinion was sought: in the time frame, there is no callus formation.This is a non-union.A lack of stability, continuous movement, and possibly even the additional pressure force on the nail due to the blocking screw led to the failure.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.No product related issue could be detected during the performed investigation of the returned device.The implant ultimately failed to withstand the applied force, resulting in material overload and fatigue failure.Based on the limited information available, the root cause of the reported event cannot be defined as this is often muti-factorial: the location of the fracture and the technical aspects of the surgical procedure could have contributed to the event.Furthermore, patient condition and activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "distal femur orif performed with single construct t2 alpha retrograde nail and interlocking 5mm screws and a blocking screw near the break site.An oblique interlocking screw was removed due to backout prominence and then at a later date the nail went on to breakage at the 6th hole of the distal cluster of interlocking screws.The surgeon and residents removed the nail and performed a ria and nail replacement using the synthes rfna retrograde femur nailing system advanced.

• Brand Name: T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D11X360MM
• 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: 23478005
• Report Number: 0008031020-2025-02046
• Device Sequence Number: 10558436
• Product Code: HSB
• UDI-Device Identifier: 07613327293593
• UDI-Public: (01)07613327293593(17)340731(10)K1C965F
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 23391136S
• Device Lot Number: K1C965F
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 122 KG