BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1923414 · Received December 13, 2010

    Report

    Report Number
    1030489-2010-01587
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUPERIOR SHAFT IS BROKEN AT THE CENTER OF THE JAW PIVOT PIN. THE BROKEN OFF PORTION OF THE SHAFT IS MISSING AND WAS NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION DISCOVERED A FAIRLY BRITTLE FRACTURE. THE LOCATION AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE, RESULTING IN THE FOREGOING EVENT. 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 THE INSTRUMENT WAS HARD TO OPEN DURING USE. ALTHOUGH THE INSTRUMENT WAS USED INTRAOPERATIVELY, NO PATIENT COMPLICATIONS WEREREPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA GZ06G133

    Patients

    Seq Age Sex Outcome Treatment
    1