BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM-STERILE

    MDR report key: 2964260 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00994
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. IMPLANTED APPROXIMATELY 2009. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS OBTAINED AND DEVICE HISTORY RECORD REVIEW WAS ATTEMPTED BUT THE LOT NUMBER DID NOT CORRESPOND TO THE PART NUMBER. THEREFORE NO EVALUATION OF MANUFACTURING RECORDS COULD BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH FEMORAL NAIL, HELICAL BLADE, AND 2 LOCKING SCREWS IN APPROXIMATELY 2009. PATIENT WAS DISCOVERED TO HAVE A NONUNION, DATE UNKNOWN. PATIENT WAS REVISED TO VA FEMORAL PLATE SYSTEM ON (B)(6) 2013. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A FALL AT HOME AND WAS IMPLANTED WITH FEMORAL NAIL, HELICAL BLADE, 2 LOCKING SCREWS, 2 COCR CABLES AND AUTO GRAFT ON (B)(6) 2009. THIS IS 1 OF 6 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67193 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM-STERILE NAIL HSB SYNTHES USA 5400067

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention AUTOGRAFT