BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA

    MDR report key: 12614462 · Received October 12, 2021

    Report

    Report Number
    1017294-2021-00342
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 12, 2021
    Manufacturer
    CONMED LARGO
    Product Code
    GFF
    UDI-DI
    10845854001028
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE ROOT CAUSE CANNOT BE IDENTIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO NOT APPLY EXCESSIVE LOADING ON THE SHAVER BLADE OR BUR. CUTTING PERFORMANCE IS NOT INCREASED WITH FORCE. EXCESSIVE FORCE OR USING SHAVER BLADES OR BURS AS A LEVER CAN CAUSE DAMAGE TO THE DEVICE INCLUDING PERMANENT DEFORMATION, SHEDDING OF METAL (WEAR), MOTOR SEIZURE AND OVERHEATING. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00509120100 (QTY (B)(4) SAME LOT) WAS BEING USED DURING A MEDIUM STRAIGHT SIDE CUT ON (B)(6) 2021 WHEN IT WAS REPORTED ¿ON THE SAME SURGERY ACT, THEY BROKE 3 TIMES ON 4 UNITS BUR 5091-201 CARBIDE MICRO SIDE-CUTTING STRAIGHT MEDIUM 6 FLUTES LOT:1072359.¿ THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. FURTHER ASSESSMENT INFORMATION WAS REQUESTED FROM THE REPORTER AND IT WAS FOUND THAT NO FRAGMENTS WERE LOST IN THE PATIENT. ANY SEEN FRAGMENTATION WAS REMOVED FROM THE PATIENT USING A HEMOSTAT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514981 1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF CONMED LARGO 5091-201 1072359 10845854001028

    Patients

    Seq Age Sex Outcome Treatment
    1