BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2201063 · Received August 11, 2011

    Report

    Report Number
    1030489-2011-01026
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL INSPECTION CONFIRMS THE TIP IS NOT BROKEN; APPROXIMATELY ~3 MM OF THE TIP HAS BEEN WORN, WITH THE LAST ~1MM OF THE TIP PLASTICALLY DEFORMED, WITH MINUTE PIECES MISSING. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER WAS BEING USED TO TIGHTEN A DOMINO CONNECTOR AND THE DRIVER TIP ROUNDED, BENT AND TWISTED OFF. NO CO MPLICATIONS WERE OBSERVED OR NOTED AS A RESULT OF THE INSTRUMENT BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA BM06J006

    Patients

    Seq Age Sex Outcome Treatment
    1