BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 6799364 · Received August 16, 2017

    Report

    Report Number
    1219602-2017-00935
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    August 3, 2017
    Report Date
    September 6, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010555694
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OUTER DIAMETER OF THE INNER BLADE SURFACE HAS WEAR DAMAGE. THIS SURFACE CONDITION INDICATES PRESSURE/FORCE WAS APPLIED TO THE DEVICE. METAL SHAVINGS CAN RESULT FROM EXCESSIVE ¿SIDE-LOADING¿ ON THE BLADE DURING USE. THERE IS DRAG FELT WITH ROTATION OF THE INNER AND OUTER BLADE. THIS IS A SYMPTOM OF DAMAGE CAUSED BY THIS PRESSURE AS WELL. AS A RESULT, BINDING, SHAVINGS AND SEIZING CAN OCCUR. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. USE ERROR MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BLADE WAS ACTIVATED, METAL FLAKES SHED FROM THE INNER BLADE. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577844 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 72200095 50654672 03596010555694

    Patients

    Seq Age Sex Outcome Treatment
    1