BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPAEDIC SURGICAL INSTRUMENT

    MDR report key: 1418705 · Received April 9, 2009

    Report

    Report Number
    1030489-2009-00345
    Event Type
    Malfunction
    Date Received
    April 9, 2009
    Date of Event
    February 27, 2009
    Report Date
    March 19, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL MACROSCOPIC EXAM SHOWS THAT APPROXIMATELY 2.13 MM PORTION OF THE TIP IS COMPLETELY SHEARED OFF. THE REMAINING FEATURE ON THE DIVER IS TWISTED COUNTER CLOCK WISE SUGGESTING THAT THE INSTRUMENT MAY HAVE BEEN SUBJECTED TO EXCESSIVE TORQUE CAUSING THE TIP TO BREAK. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS FOUND THAT THE TIP OF THE SCREW DRIVER SHAFT WAS DAMAGED/BLUNT DURING USE. WHEN THE PART WAS RETURNED AND ANALYSIS SHOWS THE TIP IS BROKEN. NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN IF THE INSTRUMENT WAS BROKEN DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPAEDIC SURGICAL INSTRUMENT SCREW DRIVER HXX MEDTRONIC SOFAMOR DANEK NA BM08B008

    Patients

    Seq Age Sex Outcome Treatment
    1