MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø11X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23311130S
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	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "primary surgery for fracture near proximal femur with t2 alpha on (b)(6)2023.But pseudoarthrosis occurred and nail broke (timing of fracture unknown).Revision surgery was performed on (b)(6) 2024.Fractured nail was removed and new nail was inserted again.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "primary surgery for fracture near proximal femur with t2 alpha on (b)(6) 2023.But pseudoarthrosis occurred and nail broke (timing of fracture unknown).Revision surgery was performed on (b)(6) 2024.Fractured nail was removed and new nail was inserted again.".
Additional Manufacturer Narrative
The received x-rays were reviewed and it can be confirmed that the nail is broken.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.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.The complaint was forwarded to medical affairs for review with following result: ¿there is very limited information available, just 2 post op x-rays and 2 x-rays after the revision procedure.What we do know: first surgery in (b)(6) 2023, revision in (b)(6) 2024 and there was a non-union of the initially treated fracture.We have more than one statement in the labeling that the nails do not replicate normal bones.It is also well known that if the fracture does not heal, eventually the implant will break.The implant is not created to carry loads indefinitely.Most probably there was not sufficient stability provided by the three proximal screws, which resulted in continuous movement, a non-union, and eventually breakage in the screw-nail interface.Based on investigation and provided information, the root cause of the reported event is multi-factorial: the location of the fracture, the choice of the implant given that location and the technical aspects of the surgical procedure.Furthermore, patient activity levels post-op may have contributed to an inadequate load distribution, and therefore the breakage of the implant.¿ no product related issue could be detected.The nail was not returned for evaluation and the provided information is limited.Therefore, it is not possible to determine the exact root cause of this event, as stated in the medical evaluation there are multiple factors that could have played a role.If more information is provided, the case will be reassessed.H3 other text : hospital retained.

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø11X300MM
• 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: 19076177
• Report Number: 0009610622-2024-00148
• Device Sequence Number: 20555793
• Product Code: HSB
• UDI-Device Identifier: 07613327284225
• UDI-Public: 07613327284225
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 23311130S
• Device Lot Number: K07D3B0
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2020
• 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