BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH-SPEED AND LOW SPEED BURS

    MDR report key: 1104263 · Received August 8, 2008

    Report

    Report Number
    1045254-2008-00019
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HIGH-SPEED TAPERED DIAMOND BUR, HIGH-SPEED CURVED ROUND DIAMOND BUR, RAD FRONTAL FINESSE BUR (LOW SPEED). EVALUATION FOUND THAT THE AMOUNT OF BONE DUST EMBEDDED IN THE DIAMOND GRIT AND BETWEEN THE BUR FLUTES, AND DRIED BLOOD ON THE BUR SHAFTS, INDICATED THAT NO IRRIGATION AT ALL WAS USED DURING SURGERY, THOUGH IRRIGATION TUBING IS SUPPLIED WITH THE PRODUCT. HEAVY PRESSURE TO ONE SIDE CAUSED ONE OF TEN RETURNED BURS TO STRETCH, TWIST, AND TEAR THE FLEXIBLE SPIRAL WRAP CAUSING THE BUR HEAD TO BREAK OFF OF THE SHAFT. THE TEN TUBING SETS WERE NOT RETURNED. THE ROOT CAUSE WAS THAT NO IRRIGATION WAS USED WITH THE BURS DURING SURGERY, CAUSING THE BURS TO GET HOT DUE TO FRICTION.

    Description of Event or Problem · 1

    A MEDTRONIC XOMED SALES REP REPORTED FOR THE HOSPITAL THAT DURING ONE FRONTAL SINUS DRILLOUT PROCEDURE, THEY WENT THROUGH TEN BURS. THE BURS GOT SO HOT THAT THEY BURNED THE PATIENT'S NOSE. SOME BURS HAD THE TIPS BREAK OFF, SOME HAD THE INNER SHAFT SHEAR OFF AT THE HUB. DR. SAID THAT AT FIRST THE IRRIGATION WAS WORKING BUT IT WOULD QUIT. SALES REP DID NOT KNOW IF IT WAS GETTING CLOGGED, OR IF THE IRRIGATION TUBING WAS BAD. DR. SAID THAT THE PATIENT IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH-SPEED AND LOW SPEED BURS SINGLE-USE ENT BURS EQJ MEDTRONIC XOMED, INC. VARIOUS NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other