BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 5005230 · Received August 14, 2015

    Report

    Report Number
    1219602-2015-00811
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    November 5, 2014
    Report Date
    November 6, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE DEVICE HAS NOT BEEN RETURNED. DUE TO THIS FACT WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. IN THE EVENT THE SAMPLES ARE RETURNED FOR EVALUATION THE COMPLAINT WILL BE REOPENED FOR ADDITIONAL INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    DURING A KNEE SCOPE PROCEDURE IT WAS REPORTED THAT METAL SHAVINGS CAME OFF THE BLADE INTO THE PATIENT. THE BROKEN PIECES WERE REMOVED VIA SUCTION. NO DELAY OR PATIENT INJURIES WERE REPORTED. A BACK-UP DEVICE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539786 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50803216

    Patients

    Seq Age Sex Outcome Treatment
    1