BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL SURGICAL BUR GUARD, MEDIUM

    MDR report key: 1162769 · Received September 8, 2008

    Report

    Report Number
    1017294-2008-00303
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    LINVATEC CORP.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AP, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION ON 8/25/2008, AND DURING TESTING FOUND THAT IT EXCEEDED TEMPERATURE SPECIFICATIONS RELATED TO A WORN BEARING. THE CUSTOMER WAS UNABLE TO IDENTIFY THE HANDPIECE SERIAL NUMBER IN USE AT THE TIME OF THIS EVENT. THREE SURGAIRTOME, TWO HANDPIECES WERE SENT IN FOR REPAIR AND DURING TESTING, NONE OF THE THREE DEVICES OVERHEATING. 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/HALL SURGICAL EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. 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 FOR SERVICE. THE CUSTOMER WILL BE PROVIDED ADDITIONAL INFORMATION ON THE CARE AND HANDLING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THIS BUR GUARD WAS IN USE WHEN THE HANDPIECE SLOWED DOWN AND HEAT WAS FELT NEAR THE COLLET END OF THE HANDPIECE. THIS EVENT PROMPTED THE USER TO DISCONTINUE USE AND OBTAIN ANOTHER UNIT TO COMPLETE THE PROCEDURE AS INTENDED. THERE WAS NO INJURY OR SURGICAL DELAY REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL BUR GUARD, MEDIUM BUR GUARD HTT LINVATEC CORP. NA BBD65214

    Patients

    Seq Age Sex Outcome Treatment
    1 NK SURGAIRTOME TWO DRILL, CATALOG#: 00505800100| SERIAL#: NK