BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL SURGICAL BUR GUARD, MEDIUM

    MDR report key: 1113323 · Received August 12, 2008

    Report

    Report Number
    1017294-2008-00289
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION. TESTING OF THIS UNIT COULD NOT BE PERFORMED DUE TO A DAMAGED/WORN BEARING. FURTHER INVESTIGATION FOUND THIS BUR GUARD IS OVERDUE FOR PREVENTATIVE MAINTENANCE. THIS DEVICE HAS NO REPAIR HISTORY WITH A MANUFACTURE DATE OF MARCH 2006. THE HANDPIECE BELIEVED TO BE IN USE AT THE TIME OF THIS EVENT WAS RECEIVED FOR EVALUATION. DURING TESTING, THIS DEVICE DID NOT OVERHEAT. FURTHER INVESTIGATION FOUND THE HANDPIECE IS WITHIN THE PREVENTIVE MAINTENANCE SCHEDULE. THE CUSTOMER WILL BE SENT ADDITIONAL INFORMATION ON CARE OF THESE PRODUCTS. THE INFORMATION FOR USE (IFU) WARNS THE USER OF THE FOLLOWING WARNINGS: PRIOR TO EACH USE, ALL EQUIPMENT MUST BE INSPECTED FOR PROPER OPERATION. OVERHEATING MIGHT OCCUR IF BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. IF OVERHEATING OCCURS, DISCONTINUE USE AND RETURN FOR SERVICE. GUARDS ARE TO BE RETURNED TO LINVATEC EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. 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. BUR GUARD TEST PROCEDURE: PRIOR TO ATTACHING THE BUR GUARD; CHECK FOR WORN BEARINGS BY INSERTING A BUR INTO THE NOSE OF THE BUR GUARD. WHILE HOLDING THE BUR, SPIN THE GUARD. THE GUARD SHOULD SPIN FREELY AROUND THE BUR SHAFT WITHOUT RESTRICTIONS. ATTACH THE BUR AND GUARD TO THE DRILL USING THE FOLLOWING INSTRUCTIONS. RUN THE INSTRUMENT FOR AT LEAST 30 SECONDS, CAREFULLY FEELING THE TIP OF THE GUARD FOR HEAT. IF HEAT IS NOTICED, DISCONTINUE USE AND RETURN TO LINVATEC/HALL SURGICAL FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS BUR GUARD WITH HANDPIECE, IT OVERHEATED. THE SURGEON FELT THE HEAT AND DISCONTINUED USE OF BOTH DEVICES. ALTERNATE DEVICES WERE OBTAINED TO COMPLETE THE PROCEDURE AS INTENDED. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL BUR GUARD, MEDIUM BUR GUARD HWE CONMED LINVATEC NA MAR06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B) (4)| CATALOG #: 00505800100| SURGAIRTOME TWO HANDPIECE