BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC FIXATION NAIL

    MDR report key: 1952115 · Received January 4, 2011

    Report

    Report Number
    2520274-2010-00260
    Event Type
    Injury
    Date Received
    January 4, 2011
    Report Date
    December 8, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON ADVISED HE HAS A PT THAT WAS IMPLANTED WITH A LONG TROCHANTERIC FIXATION NAIL APPROXIMATELY 1 1/2 YEARS AGO. RECENT X-RAY TAKEN SHOWS THE NAIL HAS BROKEN AT THE HELICAL BLADE SLOT. PT WILL BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC FIXATION NAIL TROCHANTERIC FIXATION NAIL HSB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention HELICAL BLADE