BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2122386 · Received June 13, 2011

    Report

    Report Number
    1030489-2011-00733
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPERIOR SHAFT IS SEVERELY BENT AT THE DYNAMIC JAW. THE NATURE OF THE TIP DAMAGE IS CONSISTENT WITH APPLICATION OF EXCESSIVE ROTATIONAL FORCE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE, RESULTING IN THE FOREGOING EVENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A MICRODISKECTOMY, IT WAS NOTICED THAT THE INSTRUMENT WAS MISSING THE PINS AND WOULD NOT CLOSE PROPERLY. 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 USA, INC NA GZ10L016

    Patients

    Seq Age Sex Outcome Treatment
    1