BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2771707 · Received August 29, 2012

    Report

    Report Number
    2771707
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    April 24, 2012
    Report Date
    August 29, 2012
    Manufacturer
    ARTHREX, INC.
    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

    THE 5.0 ARTHREX END CUTTER THAT THE SURGEON WAS USING CAUSED METAL SHAVINGS TO BE LEFT WITHIN THE KNEE OF THE PATIENT. THE METAL SHAVINGS WERE IRRIGATED OUT BY SURGEON BUT WE WANTED THE MANUFACTURER NOTIFIED OF THIS PROBLEM. PRODUCT WAS GIVEN TO MANAGEMENT APPROPRIATELY. THE OR NURSE MANAGER MET WITH THE SALES REP FROM ARTHREX TO DISCUSS THE INCIDENT. FROM PAST EXPERIENCE WITH SIMILAR COMPLAINTS IT IS SUSPECTED THAT THE CAUSE OF THE METAL SHAVINGS WERE CAUSED BY OPERATOR TECHNIQUE AND TOO MUCH PRESSURE MAY HAVE BEEN APPLIED. THE ARTHREX REP WILL MEET WITH THE SURGEON TO GO OVER THE PROPER TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *