BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2143334 · Received June 29, 2011

    Report

    Report Number
    1030489-2011-00823
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUALLY EVALUATED FLEX ARMS FOR FUNCTION AND RIGIDITY BY FULLY TIGHTENING AND MANIPULATING THE INSTRUMENT ARM. THE INSTRUMENT ARM WAS FOUND TO BE INSUFFICIENTLY RIGID AFTER FULL TIGHTENING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR DUE TO A WORN INTERNAL CABLE, 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 INNER CABLES ON THE ARM OF THE FLEX ARMS BROKE DURING AN ODONTOID SURGICAL PROCEDURE. ALTHOUGH THE INSTRUMENTS WERE USED IN SURGERY, 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 MY07K001

    Patients

    Seq Age Sex Outcome Treatment
    1