BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH AND NEPHEW INC.

    MDR report key: 830849 · Received March 19, 2007

    Report

    Report Number
    MW1042302
    Event Type
    Injury
    Date Received
    March 19, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 19, 2007
    Manufacturer
    SMITH AND NEPHEW INC
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 3.5 MM FULL-RADIUS SHAVER BEING USED DURING A RIGHT KNEE ARTHROSCOPY WITH PARTIAL MEDIAL MENISCECTOMY RESULTED IN METAL SHAVINGS SEEN IN RIGHT KNEE. PICTURES TAKEN INTRAOPERATIVELY. PATIENT TRANSFERRED TO PACU IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH AND NEPHEW INC. DISPOSABLE ARTHROSCOPIC SHAVER BLADE NBH SMITH AND NEPHEW INC * 357826

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability