BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2060322 · Received April 15, 2011

    Report

    Report Number
    1030489-2011-00431
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUPERIOR SHAFT IS BROKEN OFF FROM THE CENTERLINE OF THE JAW PIVOT PIN FORWARD. THE BROKEN OFF PORTION OF THE SHAFT AND BOTH SUPERIOR AND INFERIOR PIVOT PINS ARE MISSING AND NOT RETURNED FOR ANALYSIS. OPTICAL EXAMINATION OF THE FRACTURE SURFACE DISCOVERED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFTS ARE CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE. 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 "STICKING" DURING THE SURGICAL PROCEDURE. THE "JAW" APPEARED TO BE BROKEN AND INOPERABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 GZ06F067

    Patients

    Seq Age Sex Outcome Treatment
    1