BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1220265 · Received October 31, 2008

    Report

    Report Number
    1030489-2008-00607
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE HEX PORTION OF THE INSTRUMENT WAS SHEARED IN THE AREA OF THE INNER SHAFT NEAR THE TRANSITION TO THE MAIN 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 TIP OF THE DRIVER WAS BROKEN OFF WHILE TIGHTENING THE SCREW. THE TIP WAS LEFT FLUSH IN THE SCREW HEAD AND REMAINS IN THE PT. THERE WERE NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT DRIVER HXX MEDTRONIC SOFAMOR DANEK NA BL06A002

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other