BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2771347 · Received August 27, 2012

    Report

    Report Number
    2771347
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    January 27, 2012
    Report Date
    August 27, 2012
    Manufacturer
    ARTHREX
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPIC PROCEDURE ON PATIENT'S LEFT SHOULDER, ARTHREX SHAVER WAS USED. METAL SHAVINGS WERE NOTED IN THE JOINT AFTER SHAVING. SURGEON CONCERNED WITH COMPROMISED PATIENT CARE. JOINT WASHED OUT THOROUGHLY WITH 0.9 NORMAL SALINE. NO HARM TO PATIENT. DEVICE NOT RECEIVED BY CLINICAL ENGINEERING. IF RECEIVED WILL RETURN TO MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SHAVER, ARTHROSCOPY HRX ARTHREX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR