MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23371136S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a secondary fracture occurred in a patient treated 3 years earlier, with nail fracture.(event #1).Revision surgery to remove the broken nail and reinsert a new t2alphapf was performed.When drilling to the most distal round hole in the proximal part, the drill was guided by the previous screw hole and the drill was contacted with the nail.Therefore, drilling was performed with the drill sleeve held manually.After that the bore drilling was performed and an advanced locking screw was inserted to the nail".
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.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.As per event description ¿a secondary fracture occurred in a patient treated 3 years earlier, with nail fracture¿ as per further details given ¿revision surgery to remove the broken nail and reinsert a new t2alphapf was performed¿ and thus, it could not be excluded that the case of secondary fracture is rather related to insufficient healing after an implant duration of 3 years.However, due to missing item and further evidence [e.G.X-ray images] a medical statement could not be made, and a further technical statement could not be given.Finally, the ifu clearly points out that ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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: "a secondary fracture occurred in a patient treated 3 years earlier, with nail fracture.(event #1) revision surgery to remove the broken nail and reinsert a new t2alphapf was performed.When drilling to the most distal round hole in the proximal part, the drill was guided by the previous screw hole and the drill was contacted with the nail.Therefore, drilling was performed with the drill sleeve held manually.After that the bore drilling was performed and an advanced locking screw was inserted to the nail".

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X360MM
• 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: 20947615
• Report Number: 0009610622-2024-00958
• Device Sequence Number: 15502714
• Product Code: HSB
• UDI-Device Identifier: 07613327288940
• UDI-Public: (01)07613327288940(11)200306(17)300228(10)K0DE69D
• 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: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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
• Device Catalogue Number: 23371136S
• Device Lot Number: K0DE69D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2020
• 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 Age: 29 YR
• Patient Sex: Male