BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR 1883070HS 3PK FRONTAL FINESSE HI SPE

    MDR report key: 1930551 · Received December 16, 2010

    Report

    Report Number
    1045254-2010-00071
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 26, 2010
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, WITHOUT SUCCESS, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. "LOT #": THE FACILITY STATED THAT THERE WERE 3 PACKAGES WITH 3 LOT NUMBERS OPENED AND USED DURING THE PROCEDURE. THE PACKAGES WERE MIXED UP AND THE LOT WITH THE REPORTABLE EVENT COULD NOT BE DETERMINED. ALL THREE LOT NUMBERS ARE REPORTED ON SEPARATE MEDWATCH 3500A FORMS. REFERENCE MEDWATCH REPORT NUMBERS WITH CORRESPONDING LOT NUMBERS; 1045254-2010-00069 LOT 69256000, 1045254-2010-00070 LOT 68677900, AND 1045254-2010-00071 LOT 68449800. THIS IS THE FIRST REPORT OF THIS TYPE ON OF THE IDENTIFIED PRODUCT LOTS. WHILE IT IS NOT COMMON FOR A POWERED BUR TO BREAK DURING USE, OUR DATA SHOWS THAT, A SERIOUS INJURY (SI) ON RARE OCCASION, OR SURGICAL INTERVENTION IS REQUIRED DUE TO A BREAK RESULTING IN A DEVICE FRAGMENT. IN THE MAJORITY OF THESE CASES BLADE FRAGMENTS ARE EASILY REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION OR HARM, AND THE SURGERY PROCEEDS AS INTENDED WITHOUT SIGNIFICANT DELAY.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SINUS PROCEDURE THE BUR BROKE. THE BUR TIP WAS EASILY REMOVED FROM THE SURGICAL SITE AND IRRIGATION WAS USED TO INSURE NO RESIDUAL DEBRIS REMAINED. THE SURGERY PROCEEDED AS INTENDED WITHOUT ANY SIGNIFICANT DELAY. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION WITH NO ADVERSE PATIENT CONSEQUENCES, COMPLICATIONS, OR SEQUELA AS A RESULT OF THIS EVENT. ALL PORTIONS OF THE BROKEN BLADE WERE RETURNED, INDICATING THAT NO UNRETRIEVED DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THE TIP THAT SEPARATED FROM THE SHAFT MEASURED APPROXIMATELY 1 INCH. THE BREAK POINTS INCLUDED THE INNER AND OUTER SPIRAL WRAP. VISUAL INSPECTION OF THE HUBS SHOWED INDENTS IN THE LOCKING AREA OF THE OUTER HUB CAUSED BY THE HANDPIECE LOCKING MECHANISM AND DAMAGE TO THE INNER HUB CHEVRON TIPS. VISUAL INSPECTION OF THE OUTER TUBE SUPPORT AREA FOR THE TIP SHOWED GOUGES AND FLARING OF THE OUTSIDE DIAMETER. THE GOUGES ON THE OUTER TUBE CORRESPOND TO MARKS ON THE TIP. THE DAMAGE TO THE BUR INDICATES EXCESSIVE PRESSURE WAS APPLIED TO THE BUR. FUNCTIONAL INSPECTION SHOWS THAT THE BUR LOADS PROPERLY INTO THE HAND PIECE. PRODUCT IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: "EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNREMOVED BUR FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1883070HS 3PK FRONTAL FINESSE HI SPE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883070HS 68449800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention