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

Catalog Number	23311036S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "primary surgery with t2a-gt was performed on a patient with a femoral trochanteric fracture on (b)(6) 2024.The patient was admitted again because of a nail fracture on (b)(6) 2025.A revision surgery is scheduled on (b)(6) 2025 to insert a t2a-pf nail after removal of the fractured nail.".
Additional Manufacturer Narrative
The reported event could be confirmed with the provided x ray images in which we can see that the implant nail is broken.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.Hcp opinion on the received x-ray images: "little information is provided besides the x-rays.The nail broke approximately 6 months after implantation.The first x-ray (direct post-operative) show a (mal-) reduced fracture where there seems to be a significant fracture still.Unfortunately we only have one direction.The second x-ray shows the broken nail, and little to no signs of consolidation over time.Even though it is just 6 months bone healing is not happening, which could be related to the large fracture gap, the subsequent continuous movement in the fracture parts probably contributed to the failure of the nail because of metal fatigue.The general conclusion applies here: based on the provided information, the root cause of the reported event is multifactorial: the location of the fracture and the technical aspects of the surgical procedure 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." based on the hcp opinion on the provided x-rays, the root cause of the reported event is multifactorial as stated above.There are no signs of bone healing in the received x-rays which could be related to the large fracture gap.Patient activity levels post-op may also have contributed to an inadequate load distribution and the subsequent continuous movement in the fracture parts probably contributed to the failure of the nail because of metal fatigue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "primary surgery with t2a-gt was performed on a patient with a femoral trochanteric fracture on (b)(6) 2024.The patient was admitted again because of a nail fracture on (b)(6) 2025.A revision surgery is scheduled on (b)(6) 2025 to insert a t2a-pf nail after removal of the fractured nail.".

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, LEFT 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: 22564801
• Report Number: 0008031020-2025-01291
• Device Sequence Number: 3811011
• Product Code: HSB
• UDI-Device Identifier: 07613327289367
• UDI-Public: (01)07613327289367(11)221208(17)321130(10)K05462A
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 23311036S
• Device Lot Number: K05462A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2022
• 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: Unknown