BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM

    MDR report key: 863645 · Received June 7, 2007

    Report

    Report Number
    1017294-2007-00313
    Event Type
    Malfunction
    Date Received
    June 7, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 10, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE BLADE WAS RECEIVED FOR EVALUATION WITHOUT THE DETACHED PORTION. A VISUAL INSPECTION CONFIRMED THE REPORTED PROBLEM AND FOUND THE BLADE BROKE OFF AT THE SHAFT WELD. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THIS FAILURE. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YEARS SHOWS ONE SIMILAR REPORTED PROBLEM. NO INJURIES ARE ASSOCIATED WITH THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS BLADE IN AN INTRAORAL VERTICAL RAMUS OSTEOTOMY, THE BLADE BROKE IN THE PATIENT'S BONE AND WAS RETRIEVED. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM STERILE BLADE DZH CONMED LINVATEC NA BBC78398

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR MICROCHOICE OSCILLATING SAW SERIAL #: UNK| CATALOG NUMBER: 00502002400