BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2132736 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00755
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MOVING PART OF THE JAW IS BROKEN AT THE LEVER OF THE ARTICULATION. THE BREAKAGE OCCURRED AT THE SECTION WHICH IS THE MOST LOADED WHEN GRABBING TISSUES WITH THE JAWS. NO PRE-EXISTING DEFECT HAS BEEN IDENTIFIED AT THE LEVEL OF THE BROKEN SECTIONS. THE DAMAGES ARE CONSISTENT WITH APPLYING EXCESSIVE LOADS TO THE INSTRUMENTS. SOME INVESTIGATIONS HAVE BEEN PERFORMED ON THE DESIGN OF THE PITUITARY AND THE CURVED SCISSORS WHICH HAVE FOUND THAT DUE TO THE DELICATE NATURE AND THE VARIETY OF USES FOR THIS INSTRUMENT, THE ROOT CAUSE IS DETERMINED TO BE DUE TO WEAR OVER TIME AS THIS MAY REQUIRE THE USE OF GREATER FORCE ON THE INSTRUMENT WHICH COULD LEAD TO BREAKAGE. WEAR CAN ALSO OCCUR SOONER IF THE SURGEON IS USING THE INSTRUMENT FOR PURPOSES OTHER THAN THE INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PITUITARY WAS BROKEN. NO ADDITIONAL INFORMATION IS KNOWN.

    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 GZ09G031

    Patients

    Seq Age Sex Outcome Treatment
    1