BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1883673HS 3PK CHOANAL ATRESIA TAPER

    MDR report key: 2402371 · Received January 6, 2012

    Report

    Report Number
    1045254-2012-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE RETURNED PRODUCT REVEALS: THE CUTTING HEAD OF THIS BUR HAS BECOME SEPARATED FROM THE INNER SHAFT AND BECOME DISLODGED. THE BUR HEAD WAS CLEAVED AT THE FIRST SPIRAL WRAP ON THE DISTAL END. THIS PART HAS BROKEN BY AN AXIAL PULLING-FORCE BEING APPLIED TO THE BUR WHICH HAS ELONGATED THE SPIRAL WRAP DIRECTLY BEHIND THE BUR HEAD. THIS ELONGATION HAS DECREASED THE SPIRAL WRAP IN THIS AREA AND THE SUBSEQUENT APPLICATION OF ROTATIONAL FORCE TO THE SPIRAL WRAP IN APPLICATION HAS INDUCED A STRESS GREATER THAN THE YIELD STRENGTH OF THE SPIRAL WRAP LEADING TO CLEAVAGE OF THE SPIRAL WRAP AND THE SUBSEQUENT DISLODGING OF THE BUR HEAD FROM THE BUR. THE TIP WAS NOTED TO BE COMPACTED WITH BIOLOGICAL CONTAMINATION WHICH MAY INDICATE A LACK OF IRRIGATION/SUCTION AND WOULD REQUIRE EXCESS PRESSURE TO BE APPLIED DURING USE TO CUT PROPERLY. BURS ARE INTERCHANGEABLE DRILL BITS AND BURS INTENDED FOR USE WITH THE MEDTRONIC ENT AND XOMED LINE OF OTOLOGIC DRILL HANDPIECES. BURS ARE SUPPLIED IN A VARIETY OF MATERIALS FOR IMPROVED CUTTING PERFORMANCE INCLUDING: STAINLESS STEEL WITH TITANIUM NITRIDE COATING, CARBIDE AND STAINLESS STEEL, TOOL-STEEL, CARBIDE, AND STAINLESS STEEL WITH DIAMOND STUDDED HEADS. THE BURS ARE INDICATED FOR USE IN INCISING OR REMOVING BONE AND TISSUE DURING GENERAL OTORHINOLARYNGOLOGY, HEAD AND NECK, OR OTONEUROLOGICAL SURGERY. INSTRUCTIONS FOR USE PRECAUTIONS INCLUDE, BUT ARE NOT LIMITED TO: EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE WHICH MAY CAUSE INJURY. 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 ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT SERIOUS INJURY OR INTERVENTION WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED PROCEDURE, DURING USE OF A HIGH SPEED CHOANAL ATRESIA BUR, THE HEAD OF THE BIT BROKE OFF. THE PATIENT WAS NOT INJURED AND THE CASE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1883673HS 3PK CHOANAL ATRESIA TAPER BUR, EAR, NOSE AND THROAT EQJ XOMED MFG JACKSONVILLE 1883673HS 0205532948

    Patients

    Seq Age Sex Outcome Treatment
    1