BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2981202 · Received February 27, 2013

    Report

    Report Number
    1030489-2013-00637
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE DISTAL TAB BROKEN OFF ON THE SHAFT. OPTICAL EXAMINATION OF THE FRACTURE REVEALS A FAIRLY BRITTLE FRACTURE SURFACE WITH NO INDICATION OF FATIGUE. THE MORPHOLOGY OF THE FRACTURE SUGGESTS THE POSSIBLE DIRECTION OF PROPAGATION, WITH EVIDENCE OF SHEAR LIPS ON THE INTERIOR SIDE OF THE TAB. THE LOCATION OF THE FRACTURE, RELATIVE TO THE PROXIMITY TO THE HANDLE SUGGESTS POSSIBLE UNINTENTIONAL BEND STRESS OVERLOAD DURING INSTRUMENT USAGE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL REVISION PROCEDURE. DURING THE PROCEDURE, THE SURGEON NOTICED A 1CM STRIP OF METAL IN THE WOUND. IT WAS DISCOVERED THAT THE TIP OF THE DRIVER BROKE OFF DURING THE PROCEDURE. THE BROKEN PIECE WAS ABLE TO BE RETRIEVED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84316 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC GB10C010

    Patients

    Seq Age Sex Outcome Treatment
    1