BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYONICS

    MDR report key: 754504 · Received June 29, 2005

    Report

    Report Number
    MW1035889
    Event Type
    Other
    Date Received
    June 29, 2005
    Date of Event
    June 23, 2005
    Report Date
    June 24, 2005
    Manufacturer
    DYONICS, SMITH & NEPHEW, INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED CANNULA INTO KNEE FOR ARTHROSCOPIC PROCEDURE. INSTRUMENT IS USED TO FILL CAVITY WITH FLUIDS. INSTRUMENT BROKE ON INSERTION INTO KNEE. ALL PIECES RETRIEVED, NO APPARENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS SURGICAL INSTRUMENT - INFLO - OUT FLOW GEA DYONICS, SMITH & NEPHEW, INC. * 578639

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other