BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2024293 · Received March 18, 2011

    Report

    Report Number
    1030489-2011-00312
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MACROSCOPIC EXAMINATION CONFIRMS DRIVER TIP BROKEN OFF. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALS A FAIRLY BRITTLE FRACTURE SURFACE WITH RIVER LINES AND NO INDICATION OF FATIGUE OR TORSIONAL OVERLOAD. THE ANGLE OF THE FRACTURE SURFACE, IN ADDITION TO THE ABSENCE OF EVIDENCE OF TORSION OR DAMAGE TO THE MAS HEAD THREADING, USAGE, AND DIRECTION OF PLASTIC DEFORMATION SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD, WITH THE INSTRUMENT MAS HEAD THREAD LIKELY NOT FULLY ENGAGED INTO THE IMPLANT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE DUE TO INAPPROPRIATE INSTRUMENT USAGE, RESULTING IN BEND STRESS OVERLOAD AND THE SUBSEQUENT FOREGOING FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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 PATIENT UNDERWENT AN L4-ILIAC FUSION USING POSTERIOR FIXATION. DURING THE SURGERY, THE TIP OF THE DRIVER SHEARED OFF INSIDE THE SCREW HEAD.

    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 M04K0076

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR