MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23330932S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported, orif was performed on (b)(6) 2023 and the t2 alpha gt nail was implanted in the right femur of the patient.On (b)(6) 2024, the nail breakage was confirmed.The doctor's opinion is that the nail was broken because the load may have been applied on the nail due to the pseudarthrosis.The revision surgery will be performed on (b)(6) 2024.
Event or Problem Description
It was reported, orif was performed on (b)(6) 2023 and the t2 alpha gt nail was implanted in the right femur of the patient.On (b)(6) 2024, the nail breakage was confirmed.The doctor's opinion is that the nail was broken because the load may have been applied on the nail due to the pseudarthrosis.The revision surgery will be performed on (b)(6) 2024.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other was provided.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.Manufacturing and inspection records confirmed the item had been released in accordance with specs.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 the case presented a 43-year-old male patient (no data given) had been treated with above nail on (b)(6) 2023, due to an unknown fracture of the femur.Allegedly on (b)(6) 2024, nail breakage was determined and subsequently revised on alleged (b)(6) 2024.Further information, like medical records, were not provided.The implant had broken after approx.15 months.As neither implant nor medical records were provided for investigation a real root cause could not be determined.With available information a product deficiency was not verified.If further information becomes available, we reserve the rights to re-open the investigation and to re-assess the root cause assessment.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19652778
• Report Number: 0009610622-2024-00336
• Device Sequence Number: 6596448
• Product Code: HSB
• UDI-Device Identifier: 07613327286489
• UDI-Public: (01)07613327286489(11)220419(17)320331(10)K020CFE
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 23330932S
• Device Lot Number: K020CFE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2022
• 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