BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS

    MDR report key: 2080398 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00519
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF INSTRUMENT DID NOT REVEAL ANY MATERIAL OR FUNCTIONAL ISSUE IN TERMS OF FRACTURE, CRACKING, WEARING OR BREAKAGE. FUNCTIONAL EVALUATION PERFORMED ON INSTRUMENT WITH TWO SAMPLE SET SCREWS AND THREE SAMPLE BROKEN OFF SET SCREW HEADS WITHIN THE DRIVER BARREL. BOTH SCREWS WERE BROKEN OFF WITHOUT ISSUE, AND THE HEADS WERE PROPERLY RETAINED WITHIN THE INSTRUMENT. ADDITIONAL SAMPLE SET SCREW BREAK-OFF HEADS WERE PROPERLY RETAINED WITHIN THE INSTRUMENT WHEN TURNED UPSIDE DOWN. 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 WILL NOT HOLD THE BROKEN OFF PORTION OF THE BREAK OFF SETSCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA M05K0026

    Patients

    Seq Age Sex Outcome Treatment
    1 SETSCREW