BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2772297 · Received August 27, 2012

    Report

    Report Number
    2772297
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    February 2, 2012
    Report Date
    August 27, 2012
    Manufacturer
    ARTHREX
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE INVOLVED WAS A ARTHREX BONE CUTTER (5.5), REF #AR-8550BC, LOT# UNKNOWN. DURING SHOULDER ARTHROSCOPY, SURGEON NOTICED METAL SHAVING IN THE JOINT WHILE USING ARTHREX SHAVER. APPROPRIATE SHAVER SETTINGS NOTED. JOINT THOROUGHLY WASHED OUT WITH NORMAL SALINE. NO HARM TO PATIENT. DEVICE DISCARDED. ARTHREX SHAVERS ARE NOT REFURBISHED AND THE HOSPITAL HAS HAD SEVERAL PREVIOUS INCIDENTS WITH SAME BRAND. FAILED SHAVERS NOT KEPT FROM PROCEDURES. CE REQUESTED TO MANAGER THAT SHAVERS BE SAVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR