BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2467189 · Received February 24, 2012

    Report

    Report Number
    1030489-2012-00199
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. MACROSCOPIC EXAMINATION CONFIRMS HEX HEAD BROKEN OFF FROM INTERNAL SHAFT. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALED A QUA SI-BRITTLE FRACTURE SURFACE, WITH NO INDICATION OF TORSION OR FATIGUE. THE LOCATION, DIRECTION AND NATURE OF FRACTURE, IN ADDITION TO THE ANGLE OF THE PRIMARY FRACTURE PLANE SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD AS THE MECHANISM OF FAILURE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF IN A BOLT DURING BOLT REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA DC07E010

    Patients

    Seq Age Sex Outcome Treatment
    1