BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 7067468 · Received November 29, 2017

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    Report

    Report Number
    1045254-2017-00430
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 14, 2017
    Report Date
    January 29, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS INDICATES 1 OPENED AND 2 SEALED SAMPLES, PART NUMBER 1883673HS, FROM LOT NUMBER 0210640703 WERE RECEIVED. (ANALYSIS OF THE OPENED SAMPLE) THE INNER SHAFT BROKE 0.53¿ FROM THE DISTAL FACE OF THE INNER HUB WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. THE BREAK POINT CORRESPONDS TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB. THERE WERE STRIATIONS AROUND THE OUTSIDE DIAMETER OF THE BREAK POINT INDICATING METAL ON METAL CONTACT. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DAMAGE TO THE HUBS THAT IS CONSISTENT WITH IMPROPER LOADING: DIMPLES ON THE FRONT HUB PRIOR TO THE LOCKING AREA CAUSED BY THE HANDPIECE LOCKING MECHANISM; LOCKING AREA DEFORMATION CAUSED BY THE BACK SIDE OF THE FRONT COLLET OF THE HANDPIECE; AND DEFORMATION OF THE INNER HUB CHEVRONS CAUSED BY THE HANDPIECE DRIVE MECHANISM. THE INFORMATION INDICATES AN IMPROPERLY LOADED BUR CAUSED THE DEFORMATION OF THE HUBS; WHICH THEN CAUSED THE INNER SHAFT AND OUTER TUBE TO RUB TOGETHER UNTIL THE INNER SHAFT BROKE. THERE WAS NO INDICATION OF DEVICE FRAGMENTS AND THE BREAKAGE WOULD HAVE BEEN CONTAINED BY THE OUTER TUBE AND THE HANDPIECE. A BUR OR BLADE THAT IS NOT PROPERLY LOADED WOULD RESULT IN IMPROPER ENGAGEMENT WITH THE DRIVE MECHANISM OF THE HANDPIECE AND INSTABILITY OF THE BUR / BLADE. ONE OF THE SEALED SAMPLES WERE OPENED FOR THE ANALYSIS. THE BUR LOADED INTO A HANDPIECE, RAN AT 12,000 RPM IN FORWARD DIRECTION, AND CUT SAW BONE WITH NO ISSUES OR REPRODUCING ANY OF THE OBSERVE DAMAGE SEEN ON THE OPEN SAMPLE ABOVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BUR WAS FALLING APART AFTER A FEW MINUTES OF USE. IT WAS CONFIRMED THAT THE CASE WAS COMPLETED "SUCCESSFULLY BY USING A DIFFERENT BUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847335 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883673HS 0210640703

    Patients

    Seq Age Sex Outcome Treatment
    1