BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4MM ROUND BUR

    MDR report key: 10791654 · Received November 5, 2020

    Report

    Report Number
    10791654
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 23, 2020
    Report Date
    October 30, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVENT TYPE: EQUIPMENT DEVICE. DESCRIPTION OF EVENT: SURGEON OPERATING ON RIGHT FOOT AND BUR EXPLODED WHILE USING IN FOOT. ALL PIECES RETRIEVED AND X-RAY TAKEN (PORTABLE- 2 VIEWS) TO VERIFY. NO ITEMS RETAINED. NO PATIENT HARM. CONMED BUR #5092-228, LOT #1110883. DID THE PROCEDURE CHANGE OR LENGTH OF TIME EXTEND AS A RESULT OF ABOVE? APPROXIMATELY 10 MINUTES. ANY PATIENT HARM? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258376 4MM ROUND BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF CONMED CORPORATION 5092-228 1110883

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA