BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    95138

    MDR report key: 2090734 · Received May 10, 2011

    Report

    Report Number
    2090734
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 31, 2011
    Manufacturer
    STRYKER
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPY, THE PHYSICIAN NOTED METAL FRAGMENTS FROM THE SHAVER IN THE KNEE SPACE. THE PHYSICIAN STOPPED AND IRRIGATED THE SURGICAL FIELD. A NEW SHAVER WAS OBTAINED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 95138 SHAVER, BLADE GFA STRYKER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *