BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX CUSTOM X-20 TORQUE DRIVER

    MDR report key: 1592706 · Received January 27, 2010

    Report

    Report Number
    1526439-2010-00014
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2. ROOT CAUSE APPEARS TO BE MATERIAL FATIGUE RELATED TO THE APPLICATION OF ATYPICAL FORCE ON THE DRIVERS ATTEMPTING TO REMOVE THE HARDWARE IMPLANTED 7-YEARS AGO.

    Description of Event or Problem · 1

    DURING THE REMOVAL OF SPINAL HARDWARE IMPLANTED IN (B) (6) 2003 TIPS OF FOUR DRIVERS AND REMOVAL TOOLS WERE BROKE OFF. THIS RESULTED IN A DELAY TO THE CASE IN EXCESS OF 30-MIN. THE SURGEON WAS ABLE TO REMOVE THE HARDWARE AND COMPLETE THE CASE, AND THE BROKEN TIPS WERE NOT LEFT IN THE PT. TWO OF THESE DRIVERS WERE DEPUY SPINE AND MDRS ARE BEING FILED TO DOCUMENT THIS EVENT. DEVICE 2. SEE 1526439-2010-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SFX CUSTOM X-20 TORQUE DRIVER MANUAL SURGICAL INSTRUMENT HXX DEPUY SPINE, INC. NA 0209N

    Patients

    Seq Age Sex Outcome Treatment
    1