BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1883070HS 3PK FRONTAL FINESSE HI SPE

    MDR report key: 2083483 · Received May 10, 2011

    Report

    Report Number
    1045254-2011-00031
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE WAS OUT OF SPECIFICATION IN AN AS RECEIVED CONDITION. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT PROBLEM HAS CAUSED AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. NO ADVERSE EVENT WAS INDICATED, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    DESCRIPTION OF THE ORIGINAL COMPLAINT: "THE BUR BROKE OFF IN THE PATIENT'S NOSE DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT." THE PORTION OF THE BUR THAT BECAME DETACHED MEASURED APPROXIMATELY 5/8 INCH LONG. THE PIECE CONSISTED OF THE CUTTING TIP AND A PORTION OF THE SPIRAL WRAP. THE INNER AND OUTER SPIRAL WRAP FAILED JUST BEHIND THE WORKING TIP. THE SUPPORT AREA AT THE END OF THE INNER TUBE SHOWED HEAVY GOUGING AND CORRESPONDING DAMAGE IN THE OUTER TUBE SUPPORT AREA INDICATING THAT EXCESSIVE PRESSURE HAD BEEN APPLIED DURING USE. ALL PORTIONS OF THE BUR WERE RECEIVED INDICATING THAT THERE WERE NO UNRETRIEVED DEVICE FRAGMENTS. IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: DISCONTINUE POWERED APPLICATION IN THE EVENT OF LACK OF VISUALIZATION OF THE SURGICAL SITE. ALWAYS INSPECT THE COMPONENTS BEFORE AND AFTER USE FOR ANY DAMAGE. IF DAMAGE IS OBSERVED, DO NOT USE DAMAGED PART UNTIL IT IS REPLACED. DAMAGED PARTS MAY DEPOSIT METAL SHAVINGS ON SURGICAL SITE. 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 EQJ MEDTRONIC XOMED INC. 1883070HS 62671000

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR