BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2182420 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00958
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    FUNCTIONALLY EVALUATED FLEX ARM RIGIDITY BY MANUALLY FULLY TIGHTENING AND MANIPULATING THE INSTRUMENT. THE INSTRUMENT TIP WAS I NSUFFICIENTLY RIGID AFTER FULL TIGHTENING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR DUE TO A WORN INTERNAL CABLE, RESULTING IN THE FOREGOING EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLEX ARMS WOULD NOT STAY FIXATED AND THE SCREW IS STRIPPED ON THE ARMS. NO COMPLICATIONS WERE OBSERVED OR NOTED AS A RESULT OF THE INSTRUMENT MALFUNCTIONING.

    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 MY10K001

    Patients

    Seq Age Sex Outcome Treatment
    1