BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 2111538 · Received May 26, 2011

    Report

    Report Number
    2111538
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 26, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    SURGEON USING THE ARTHROSCOPIC SURGICAL BLADE ON A FEMALE PATIENT'S SHOULDER (EXACT PHYSICAL LOCATION WITHIN SHOULDER STRUCTURE IS UNKNOWN) WHEN METAL FRAGMENT WAS SEEN IN THE SURGICAL SITE DURING USE. THE TIP OF THE BLADE HAS WHAT APPEARS TO BE A MISSING PORTION ON CLOSE EXAMINATION. DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS ARTHROSCOPIC SURGICAL BLADE HAB SMITH & NEPHEW ENDOSCOPY 7205668 50559741

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR