BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN OSCILLATOR BLADE, BRAZOL COATED

    MDR report key: 1000256 · Received February 14, 2008

    Report

    Report Number
    1017294-2008-00109
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Report Date
    January 17, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: AN EVALUATION COULD NOT BE PERFORMED BECAUSE THE DEVICE IS NOT BEING RETURNED TO THE MFR. A REVIEW OF COMPLAINT RECORDS AT CONMED LINVATEC FOUND SIMILAR REPORTED PROBLEMS. CONMED LINVATEC FOUND THAT THIS TYPE OF DAMAGE CAN OCCUR DURING USE IF THE BLADE TEETH COME IN CONTACT WITH OTHER METAL INSTRUMENTS SUCH AS THE CUTTING BLOCK OR RETRACTORS THAT ARE HARDER THAN THE BLADE TEETH ITSELF. IN ADDITION, ACTIVATION OF THE SAW WHILE INSERTING OR REMOVING THE BLADE FROM THE CUTTING BLOCK CAN CAUSE TEETH DAMAGE AND POSSIBLE BREAKAGE. THE SURGEON WILL BE CONTACTED WITH INFO REGARDING THIS REPORTED EVENT. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.

    Description of Event or Problem · 1

    THE SURGEON REPORTED, THAT DURING USE OF THIS BLADE IN A TOTAL KNEE SURGERY, THE TEETH AND HUB BROKE. TO DATE, THERE IS NO REPORT OF INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN OSCILLATOR BLADE, BRAZOL COATED OSCILLATING BLADE, 19.5 X 86 X 1.27MM HWE CONMED LINVATEC NA BBD15572

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ZIMMER NEXGEN TOTAL KNEE SYSTEM