BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN OSCILLATOR BLADE, BRAZOL COATED

    MDR report key: 1243081 · Received November 21, 2008

    Report

    Report Number
    1017294-2008-00346
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 30, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THIS DEVICE HAS NOT BEEN RETURNED FROM THE CUSTOMER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON RECEIPT OF THE DEVICE AND COMPLETION OF AN EVALUATION. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS OSCILLATING BLADE, METAL SHAVINGS WERE DISPERSED ON THE BONE AND WERE NOT ALL RETRIEVED. THERE WAS NO SERIOUS INJURY OR SURGICAL DELAY REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN OSCILLATOR BLADE, BRAZOL COATED SURGICAL INSTRUMENT MOTOR ACCESS/ATTACH HWE CONMED LINVATEC NA BBD68102

    Patients

    Seq Age Sex Outcome Treatment
    1 NK NK