BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX

    MDR report key: 4189714 · Received October 14, 2014

    Report

    Report Number
    MW5038659
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 14, 2014
    Manufacturer
    CONMED LINVATEC BIOMATERIALS, LTD
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SHOULDER ARTHROSCOPY, USED 6.0 BURR AND WHEN REMOVING BURR FROM PORT IT BROKE OUTSIDE THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648740 VORTEX BURR, 6.0 MM HRX CONMED LINVATEC BIOMATERIALS, LTD LM305300025 A L045 122049

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR