BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPIC SHAVER FULL RADIUS 3.5 MM

    MDR report key: 3905831 · Received June 25, 2014

    Report

    Report Number
    MW5036907
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER SUSTAINABLILITY SOLUTIONS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARTHROSCOPIC SHAVER FULL RADIUS 3.5 M (REPROCESSED) USED DURING PROCEDURE WITH METAL SHAVINGS FROM DEVICE NOTED ON VIDEO. SHAVER TIP REMOVED, METAL SHAVINGS REMOVED WITH ARTHROSCOPIC SUCTION AND VISUALIZATION. NO HARM OR INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370303 ARTHROSCOPIC SHAVER FULL RADIUS 3.5 MM ARTHROSCOPIC SHAVER HRX STRYKER SUSTAINABLILITY SOLUTIONS 7205305 2883629

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention