BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 140MM

    MDR report key: 2192739 · Received May 27, 2011

    Report

    Report Number
    3005985723-2011-00014
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MAKO SURGICAL
    Product Code
    JDW
    PMA / PMN Number
    K081867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BONE PIN INVOLVED WITH THE EVENT WAS NOT RETURNED. AN INVESTIGATION WAS INITIATED, AND IS ON-GOING. THE RISK OF BONE PIN BREAKAGE IS NOT UNIQUE TO OUR PROCEDURE AND IS A WELL KNOWN AND ACCEPTED RISK IN COMPUTER-ASSISTED SURGERIES AND OTHER PROCEDURES REQUIRING FIXATION TO BODY STRUCTURES. IF BONE PINS FROM THE SAME LOT CAN BE RECOVERED, AND ADDENDUM WILL BE FILED TO THE MDR WITH THE RESULTS OF THE TESTING.

    Description of Event or Problem · 1

    TIP OF 3.2 X 80 MM BONE PIN BEING FIRST INSERTED SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE PIN, 3.2MM X 140MM PIN, FIXATION, THREADED (JDW) JDW MAKO SURGICAL 111620

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR