BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM X 19CM HPS PREBENT POLISHING BUR

    MDR report key: 17508416 · Received August 11, 2023

    Report

    Report Number
    1017294-2023-00072
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 13, 2023
    Report Date
    September 8, 2023
    Manufacturer
    CONMED LARGO
    Product Code
    GFF
    UDI-DI
    10845854029886
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. 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. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 4 COMPLAINTS, REGARDING 5 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 10,996 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0005. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: DO 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-HB02, 4.5MM X 19CM HPS PREBENT POLISHING BUR, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 13JUL23 WHEN IT WAS REPORTED, ¿DOCTOR (NAME) WENT INTO SCOPE THE HIP, AND AS SOON AS HE CONTACTED BONE, THE BURR FRAGMENTED INTO PIECES INSIDE THE PATIENT HIP. DR. RECOVERED ALL FRAGMENTS FROM THE BURR TRIED AGAIN WAS SAME LOT NUMBER HIP BURR AND HAD THE SAME RESULTS. THE BURR WAS SENDING FRAGMENTS INTO PATIENT'S HIP UPON CONTACT OF BONE. DOCTOR BELIEVES THAT IT WAS THE BURR MAKING CONTACT WITH THE BURR GUARD WHICH WAS CAUSING IT TO FRAGMENT.¿. THERE WAS NO INITIAL REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. ALL FRAGMENTATION WAS RECOVERED FROM THE PATIENT PER THE REPORTER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-HB02, 4.5MM X 19CM HPS PREBENT POLISHING BUR, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿DOCTOR (NAME) WENT INTO SCOPE THE HIP, AND AS SOON AS HE CONTACTED BONE, THE BURR FRAGMENTED INTO PIECES INSIDE THE PATIENT HIP. DR. RECOVERED ALL FRAGMENTS FROM THE BURR TRIED AGAIN WAS SAME LOT NUMBER HIP BURR AND HAD THE SAME RESULTS. THE BURR WAS SENDING FRAGMENTS INTO PATIENT'S HIP UPON CONTACT OF BONE. DOCTOR BELIEVES THAT IT WAS THE BURR MAKING CONTACT WITH THE BURR GUARD WHICH WAS CAUSING IT TO FRAGMENT.¿. THERE WAS NO INITIAL REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. ALL FRAGMENTATION WAS RECOVERED FROM THE PATIENT PER THE REPORTER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727635 4.5MM X 19CM HPS PREBENT POLISHING BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF CONMED LARGO 1313058 10845854029886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown