BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGAIRTOME TWO HANDPIECE

    MDR report key: 1003719 · Received February 20, 2008

    Report

    Report Number
    1017294-2008-00134
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE DEVICE FORE EVALUATION AND CONFIRMED THE REPORTED PROBLEM. DURING TESTING OF THIS HANDPIECE, IT GOT HOT IN THE COLLET. FURTHER INVESTIGATION FOUND COLLET CORROSION AND A WORN SPINDLE, WHICH PREVENTED THE BUR FROM SECURELY LOCKING INTO THE COLLET. IN ADDITION, THIS UNIT IS OVERDUE FOR PREVENTATIVE MAINTENANCE; LAST SERVICE DATE IDENTIFIED IS FEBRUARY 2006. THE BUR GUARD IN USE AT THE TIME OF THIS EVENT WAS TESTED WITH THIS HANDPIECE AND PERFORMED TO SPECIFICATION. LAST REPAIR DATE FOR THIS BUR GUARD WAS JANUARY 2008, WHICH IS WITHIN THE 6 MONTH PREVENTIVE MAINTENANCE SCHEDULE. AS CERTAIN INTERNAL COMPONENTS (I.E. BEARINGS) ARE KNOWN TO DEGRADE WITH USE, CLEANING, STERILIZATION CYCLES, AND/OR LACK OF PREVENTATIVE MAINTENANCE, CONMED LINVATEC RECOMMENDS THAT THE SURGAIRTOME TWO HANDPIECES BE RETURNED TO THE FACTORY FOR ROUTINE MAINTENANCE EVERY TWELVE (12) MONTHS. FAILURE TO FOLLOW THIS ROUTINE MAINTENANCE SCHEDULE MAY RESULT IN OVERHEATING OR DAMAGE TO THE HANDPIECE AND/OR BUR GUARD AND MAY RESULT IN INJURY TO PATIENTS OR THE MEDICAL PERSONNEL.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING USE OF THIS DRILL IN A THIRD MOLAR EXTRACTION, HE FELT HEAT IN THE BODY OF THE HANDPIECE, AND DISCONTINUED USING THE DEVICE. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGAIRTOME TWO HANDPIECE HIGH SPEED DRILL DZA CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BUR GUARD| CATALOG #: 1375-12 & LOT #: JAN08S