BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X360MM

    MDR report key: 16048862 · Received December 26, 2022

    Report

    Report Number
    0009610622-2022-00601
    Event Type
    Injury
    Date Received
    December 26, 2022
    Date of Event
    December 2, 2022
    Report Date
    March 1, 2023
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    07613327285994
    PMA / PMN Number
    K203819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED NAIL WAS FOUND TO BE BROKEN FROM ALMOST MID PORTION I.E. SHAFT OF THE NAIL. OVERALL, THE FRACTURE PATTERN REVEALS A FATIGUE FAILURE EVIDENT BY THE APPEARANCE OF LINES OF REST. JUST OPPOSITE TO THE ORIGIN POINT OF THE BREAKAGE, PLASTIC DEFORMATION OF EDGES, EVIDENT BY SHINY SURFACE, COULD BE OBSERVED INDICATING TOWARDS EXCESSIVE LOADING OVER A CONSIDERABLE PERIOD OF TIME. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON THE EVIDENCES FROM THE DEVICE INSPECTION AND THE AVAILABLE INFORMATION LIKE A POTENTIAL NON-UNION (CANNOT BE CONFIRMED WITHOUT X-RAY EXAMINATION), THE MOST LIKELY CAUSE OF THE FAILURE IS PATIENT RELATED. THE FACT THAT THE NAIL BROKE ALMOST AFTER 8 MONTHS INDICATES TOWARDS A POTENTIAL NON-UNION. IT CANNOT BE EXCLUDED THAT A SUBOPTIMAL FRACTURE REDUCTION/TREATMENT COULD ALSO BE A REASON FOR NON-UNION AND SUBSEQUENT NAIL BREAKAGE, BUT X-RAYS ARE NEEDED TO CONFIRM THAT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NAIL BROKE AND A REVISION SURGERY WAS PERFORMED. ADDITIONALLY A NONUNION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NAIL BROKE AND A REVISION SURGERY WAS PERFORMED. ADDITIONALLY A NONUNION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137045 FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X360MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL 2333-1036S K08E770RA 07613327285994

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention