BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE MERLIN, CUDA, 15 DEGREES CURVED 4.2MM

    MDR report key: 1000254 · Received February 14, 2008

    Report

    Report Number
    1017294-2008-00147
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 17, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: AN INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED TO THE MFR. A REVIEW OF PRODUCT HISTORY SHOWS OTHER SIMILAR REPORTS FOR METAL SHAVINGS. THIS TYPE OF PROBLEM CAN OCCUR IF EXCESSIVE LATERAL FORCE IS APPLIED DURING USE OR IF THERE IS INSUFFICIENT LUBRICATION BETWEEN THE INNER AND OUTER BLADE. THE EXCESSIVE FORCE CAN CAUSE FRICTION AND WEAR ON THE BLADE. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFO REGARDING THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS SHAVER BLADE IN A KNEE ARTHROSCOPY PROCEDURE, METAL SHAVINGS WERE OBSERVED IN THE JOINT. THE SURGEON FLUSHED THE KNEE, HOWEVER, IT IS UNK IF ALL METAL SHAVINGS WERE REMOVED FROM THE JOINT. THERE WAS NO REPORT OF PT INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE MERLIN, CUDA, 15 DEGREES CURVED 4.2MM CUDA, CURVED 4.2 MM GFA CONMED LINVATEC NA BBD42622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK