MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, LEFT D9X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23310936S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2022 with t2 alpha gt nail.During the follow-up, the doctor was aware that it was a non-union, but he was not going to revision surgery.However, on (b)(6), it was discovered that the nail had broken off.It is scheduled to be removed and replaced with an artificial head on (b)(6) 2025.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event of nail breakage could be confirmed based on x-ray image provided, only.The nail was found to be broken at the proximal end at the area of lag screw bore hole.In the case presented a female patient, (b)(6) years old at time of event, was initially treated with above shown implant on (b)(6) 2022, which was noticed to be broken as per event date given on (b)(6) 2025 after an implant duration of 3 years.As per event description ¿ it is scheduled to be removed and replaced with an artificial head on (b)(6) 2025 ¿, which could be seen as a hint that sufficient healing is no longer be expected.The op tech clearly points out as following ¿ the patient should be advised 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 or trauma and that the device has a finite expected service life ¿ removal or revision of the device may be required sometime in the future due to medical reasons.¿ the t2 alpha femoral nail is designed for temporary implantation until bone consolidation occurs.If bone consolidation does not occur or if the consolidation is insufficient, the implant may break ¿ furthermore, adverse events and adverse effects are rather clinical than device related and clearly stated in the ifu.Revision and additional surgery may be a consequence of these complications.Provided x-ray image was forwarded to an hcp for review and comments ¿ his excerpts: ¿ the implant was placed in 2022, not sure when the non-union was diagnosed, but the x-ray of the broken nail still shows no healing of the fracture and the revision was done in 2025.Clearly 3 years without clear signs of callus etc, this is a non-union ¿ based on the above it could not be excluded that the case is linked to insufficient healing, which is supported by event description- non-union; confirmed by x-ray image available- and thus, to be classified as patient-patient factors issue.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2022 with t2 alpha gt nail.During the follow-up, the doctor was aware that it was a non-union, but he was not going to revision surgery.However, on (b)(6), it was discovered that the nail had broken off.It is scheduled to be removed and replaced with an artificial head on (b)(6) 2025.".

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, LEFT D9X360MM
• 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: 22736303
• Report Number: 0008031020-2025-01327
• Device Sequence Number: 7218417
• Product Code: HSB
• UDI-Device Identifier: 07613327284812
• UDI-Public: (01)07613327284812(11)210316(17)310228(10)K0ECE6B
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 23310936S
• Device Lot Number: K0ECE6B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• 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: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian