BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2101017 · Received May 24, 2011

    Report

    Report Number
    1030489-2011-00618
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INFERIOR SHAFT IS BROKEN AT THE CENTER OF THE JAW PIVOT PIN FORWARD. OPTICAL EXAMINATION IDENTIFIED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE, RESULTING IN THE FOREGOING EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE MICRO-DISCECTOMY IT WAS NOTICED THE INSTRUMENT MOUTH WASN'T OPENING AND CLOSING CORRECTLY. AFTER THE CLOSELY INSPECTION, IT WAS FOUND THAT A BROKEN DISTAL END TO THE INSTRUMENT. NO COMPLICATIONS WERE OBSERVED OR NOTED AS A RESULT OF THE INSTRUMENT BREAKING.

    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 GZ10E060

    Patients

    Seq Age Sex Outcome Treatment
    1