BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1070062 · Received July 3, 2008

    Report

    Report Number
    1030489-2008-00310
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE HEX PORTION COMPLETELY BROKEN FROM THE INSTRUMENT. BREAKAGE LIKELY DUE TO OVER STRESSING AND FATIGUE FROM REPEATED USAGE. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT ADDITIONAL SURGERY TO REMOVE A LOOSENED CROSSLINK. DURING THE REVISION, THE TIP OF THE HEX HEAD SCREWDRIVER WAS BROKEN OFF INSIDE THE CROSSLINK SETSCREW. AT THIS POINT, THE SURGEON WAS UNABLE TO REMOVE THE CROSSLINK AND DECIDED TO LEAVE IT IN, AS HE DID NOT FEEL THAT IT POSED ANY HEALTH CONCERN TO THE PATIENT. THE BROKEN TIP REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX WARSAW ORTHOPEDIC INC. NA 35936

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other