BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD FRONTAL FINESSES HIGH SPEED BUR

    MDR report key: 1082598 · Received July 23, 2008

    Report

    Report Number
    1045254-2008-00017
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED BUR BY ENGINEERING FOUND THAT THE BUR HEAD SEPARATED FROM THE SHAFT AND WAS RETURNED. THE FLEXIBLE SPIRAL WRAP BUR SHAFT STRETCHED UNTIL IT TORE. THE WELDS THAT ATTACH THE BUR HEAD TO THE SPIRAL WRAP ARE IN GOOD CONDITION. ROOT CAUSE WAS DETERMINED TO BE EXCESS PRESSURE APPLIED TO ONE SIDE OF THE BUR WHILE DRILLING.

    Description of Event or Problem · 1

    A MEDTRONIC OF CANADA SALES REPRESENTATIVE WAS IN THE OR DURING A CASE WHERE THEY WERE USING THE HIGH SPEED BUR. THE TIP OF THE BUR ACTUALLY BROKE INSIDE A PATIENT, BUT THE PIECE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAD FRONTAL FINESSES HIGH SPEED BUR SINGLE-USE SINUS RESECTION BUR EQJ MEDTRONIC XOMED INC. 1883070HS 54268200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other