BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER

    MDR report key: 3192292 · Received June 26, 2013

    Report

    Report Number
    3192292
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    BEAVER BLADE SNAPPED IN HALF DURING HIP SCOPE - PIECE WAS RETRIEVED . BOTH PIECES MATCH TOGETHER. C-ARM WAS BEING UTILIZED DURING CASE, SO NO ADDITIONAL DIAGNOSTIC TESTING REQUIRED. TEAM RECOVERED BOTH PIECES AND FOLLOWED POLICY BY HAVING THE FILM READ BY A RADIOLOGIST. NO APPARENT HARM TO THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289536 BEAVER ARTHROSCOPE HRX SMITH & NEPHEW, INC 72203307 3030178

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR