BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 4906602 · Received July 10, 2015

    Report

    Report Number
    1045254-2015-00228
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 21, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS FOUND THAT 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 DAMAGE CAUSED BY THE BACK SIDE OF THE FRONT COLLET OF THE HANDPIECE; AND DAMAGE TO THE INNER HUB CHEVRONS CAUSED BY THE HANDPIECE DRIVE MECHANISM. THE INNER SHAFT BROKE 0.72¿ FROM THE DISTAL FACE OF THE INNER HUB. THE BREAK POINT CORRESPONDS TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DEFORMATION OF THE LOCKING AREA ON THE FRONT HUB AND STRIATIONS AROUND THE OUTSIDE DIAMETER OF THE BREAK POINT INDICATING METAL ON METAL CONTACT. THERE WAS NO INDICATION OF DEVICE FRAGMENTS AND THE BREAKAGE WOULD HAVE BEEN CONTAINED BY THE OUTER TUBE AND THE HANDPIECE. NOTE: THE OBSERVED DAMAGE HAS PREVIOUSLY BEEN REPRODUCED BY USING EXCESS FORCE DURING USE AND IMPROPERLY LOADING A BLADE INTO A HANDPIECE WITH A RESERVE SAMPLE BLADE. THE INSTRUCTIONS FOR USE HAS DETAILED INSTRUCTIONS FOR PROPERLY LOADING A BUR/BLADE INTO THE HANDPIECE AND WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE DIAMOND BUR BROKE OFF DURING THE PROCEDURE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, AND THE INCIDENT CAUSED NO DELAY OR ADVERSE EFFECT TO THE PATIENT. NO DEBRIS WAS PRODUCED FROM THE BROKEN BUR.¿ IT WAS CONFIRMED THAT NO FRAGMENTS WERE PRODUCED BY THIS BREAK, AND THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448929 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1885061HS 0208937944

    Patients

    Seq Age Sex Outcome Treatment
    1