BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1181757 · Received September 18, 2008

    Report

    Report Number
    1030489-2008-00525
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION DETERMINED A TORSIONAL FORCE GREATER THAN THE INSTRUMENT COULD WITHSTAND WAS APPLIED CAUSING THE TIP OF THE INSTRUMENT TO SEPARATE FROM THE SHAFT. 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 T20 DRIVER TIP WAS BROKEN OFF WHILE TIGHTENING THE AXIAL CONNECTOR. THE BROKEN FRAGMENT WAS RETRIEVED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT DRIVER HXX MEDTRONIC SOFAMOR DANEK NA BM05H005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK