BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 5732926 · Received June 17, 2016

    Report

    Report Number
    1045254-2016-00194
    Event Type
    Malfunction
    Date Received
    June 17, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBER: 1899200 ¿ MICRODEBRIDER, M5; SERIAL NUMBER ¿ (B)(4); LOT NUMBER ¿ 209435003; 510K NUMBER ¿ K081277; PRO CODE - ERL. INITIAL REPORT OCCUPATION: OR TEAM LEAD. XOM UNKNOWN BUR: A PORTION OF THE HIGH SPEED BUR WAS RETURNED, STUCK INSIDE AN M5 HANDPIECE. A BLUE HUB CONFIRMS THAT IT WAS A HIGH SPEED BUR. HOWEVER, NO TESTING COULD BE PERFORMED AS ONLY A PORTION OF THE BROKEN BUR WAS RECEIVED. 1899200 (MICRODEBRIDER M5): THE PRODUCT ANALYSIS INDICATES THAT THERE WAS A BLUE BUR BROKEN OFF IN THE HANDPIECE. THE HANDPIECE WAS DISASSEMBLED. THE BROKEN BUR WAS REMOVED AND IN CONSIDERATION OF NORMAL WEAR AND TEAR, THE REAR SEAL AND BEARING CUP ASSEMBLY WAS REPLACED. THE HANDPIECE WAS REPAIRED, CLEANED, TESTED, AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH SPEED BUR BROKE DURING USE, WHICH DID NOT RESULT IN FRAGMENTS. THE BUR WAS STUCK IN THE HANDPIECE AND WHILE TRYING TO REMOVE IT, A PORTION OF THE BUR BROKE OFF. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388163 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. XOM UNKNOWN BUR

    Patients

    Seq Age Sex Outcome Treatment
    1