BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWTI AWL

    MDR report key: 2619074 · Received June 18, 2012

    Report

    Report Number
    1526439-2012-00121
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 18, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE CONDITION OF THE DEVICE PRIOR TO BREAKAGE AND FORCE APPLIED ARE UNKNOWN. THE DEVICE IS OVER SEVEN YEARS OLD. DEVICE MAY HAVE BEEN WORN FROM NORMAL WEAR AND TEAR, HOWEVER, THIS CANNOT BE CONFIRMED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL END OF THE AWL FRACTURED AND SEPARATED FROM THE HANDLE AFTER PENETRATING THE CORTEX OF THE L5 VERTEBRAL BODY. AS IT WAS FULLY EMBEDDED IN THE BONE, IT WAS DECIDED TO BE SAFER FOR THE PATIENT TO BE LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOWTI AWL MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM BW1104

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR