BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM ROUND DIAMOND BUR X-LONG

    MDR report key: 11344306 · Received February 18, 2021

    Report

    Report Number
    1017294-2021-00060
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    December 28, 2020
    Report Date
    April 2, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED ISSUE AND COMPLAINT OF THE BUR HEAD BLADE COMING OFF WHILE THE CUSTOMER WAS USING THE BUR WAS CONFIRMED. THE RETURNED USED DEVICE, ITEM 00509326200 FOUND THE BUR HEAD AND THE BUR SHAFT BURNED AND DAMAGED FROM EXCESSIVE HEAT. IT WAS FOUND THAT PARTS OF THE DIAMOND BUR TIP WERE SEPARATED AND DEFORMED. IT IS SUSPECTED THAT EXCESSIVE FORCE (LOAD) WAS USED DURING PROCEDURE. THIS IS TECHNIQUE DEPENDENT DEVICE AND THE MOST LIKELY CAUSE OF THIS SUSPECTED FAILURE IS USER RELATED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. (B)(4). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ALSO ADVISES THE USER TO AVOID LATERAL STRESSES TO THE INSTRUMENT OR DEVICE FUNCTION MAY BE COMPROMISED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RECEIVED INTO CONMED'S COMPLAINT SYSTEM FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON BEHALF OF THE CUSTOMER, THE DISTRIBUTOR IN (B)(6) REPORTED ISSUES REGARDING A 3MM ROUND DIAMOND BUR X-LONG, ITEM # (B)(4), (5093-262) LOT # 1117441 THAT THE(B)(6) HOSPITAL EXPERIENCED ON (B)(6) 2020. INFORMATION RECEIVED WAS THAT "THE BUR HEAD BLADE HAD COME OFF WHILE THE CUSTOMER WAS USING THE BUR". IT IS INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT USING AN ALTERNATE DEVICE. CLARIFICATION WAS RECEIVED THAT INDICATES THE BUR WAS BEING ACTIVELY USED IN THE PATIENT WHEN THE COATING ON THE BLADE PEELED OFF. THE COATING CAME INTO CONTACT WITH PATIENT, BUT IT IS INDICATED ALL WAS REMOVED. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS THE PEELED OFF COATING WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243330 3MM ROUND DIAMOND BUR X-LONG BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF CONMED CORPORATION 1117441

    Patients

    Seq Age Sex Outcome Treatment
    1