BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIMING ARM

    MDR report key: 1780773 · Received July 27, 2010

    Report

    Report Number
    2520274-2010-00144
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 13, 2010
    Report Date
    July 2, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. MANUFACTURE SITE AND MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER. COULD NOT BE DETERMINED WITHOUT A CATALOG 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

    DURING A PROCEDURE TO PLACE A SHORT TFN, THE INSERTION HANDLE AND AIMING ARM DID NOT ALIGN WITH THE NAIL PROPERLY. THE DRILL BENT WENT POSTERIOR TO THE NAIL AND WHEN IT CAME IN CONTACT WITH THE FEMUR, THE FEMUR FRACTURED. THE SURGEON REMOVED THE SHORT TFN AND REPLACED IT WITH A LONG TFN AND WAS ABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIMING ARM AIMING ARM LXH SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention INSERTION HANDLE