BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTETRAK

    MDR report key: 1832259 · Received August 30, 2010

    Report

    Report Number
    1832259
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 30, 2010
    Manufacturer
    EXACTECH, INC
    Product Code
    HRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER OPERATIVE REPORT, WHILE PLACING THE HOLDING PIN FOR THE CUTTING BLOCK ON THE PATIENT'S RIGHT KNEE DURING A RIGHT TOTAL KNEE REPLACEMENT, THE PIN WAS BROKEN. AN ATTEMPT WAS MADE TO REMOVE THE HEADLESS PIECE OF THE PIN, BUT IT WAS QUITE DEEP AND COULD NOT BE RETRIEVED AND WAS LEFT IN-SITU. THE BROKEN PIECE OF THE PIN WITH THE HEAD WAS SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK HOLDING PIN HRY EXACTECH, INC 201-78-12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR