BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3181349 · Received June 21, 2013

    Report

    Report Number
    1030489-2013-02445
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. :THE INSTRUMENT'S SHAFTS ARE BROKEN APPROXIMATELY 60MM FROM THE BASE OF THE HANDLE. OPTICAL EXAMINATION IDENTIFIED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. ADDITIONALLY, A FRAGMENT IS MISSING FROM THE EDGE OF THE BROKEN SHAFT, CONSISTENT WITH OF IMPACT AND/OR DROP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MICRO DISCECTOMY PROCEDURE, THE PITUITARY BROKE IN THE MIDDLE. IT WAS VERIFIED VIA FLOUROSCOPY THAT NO PIECES OF THE PITUITARY WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283148 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA GZ05G047

    Patients

    Seq Age Sex Outcome Treatment
    1