BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS DISPOSABLE ARTHROSCOPIC BLADES

    MDR report key: 2213142 · Received August 12, 2011

    Report

    Report Number
    2213142
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 12, 2011
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DYONICS ARTHROSCOPIC SURGICAL BLADE BEING USED DURING RIGHT KNEE ARTHOSCOPY BROKE. THE TIP OF BLADE THAT BROKE WAS RETRIEVED WITHOUT INCIDENT OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS DISPOSABLE ARTHROSCOPIC BLADES SURGICAL BLADE HRX SMITH & NEPHEW * 50577994

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR