BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 25206559 · Received May 18, 2026

    Report

    Report Number
    1017294-2026-00116
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 18, 2026
    Manufacturer
    CONMED
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 00507112400, OSCILLATOR BLADE, 25.4 X 95 X 1.27 MM (.050") DEVICE WAS USED IN A TOTAL KNEE PROCEDURE ON (B)(6) 2026, AND ¿BLADE BROKE OFF DURING SURGERY. PIECES DID FALL INTO PATIENT- SURGEON BELIEVES HE RETRIEVED THEM ALL¿. THERE WAS A DELAY OF ¿10-20 MIN LOOKING FOR PIECES¿ AND ¿STAFF/ SURGEON SAID ALL PIECES WERE RETRIEVED". THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE 5071-167 DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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
    599715 CONMED BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA CONMED 1543896

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male