BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 140MM

    MDR report key: 2335035 · Received October 14, 2011

    Report

    Report Number
    3005985723-2011-00035
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    MAKO SURGICAL .
    Product Code
    JDW
    PMA / PMN Number
    K081867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL # 111670. ADDITIONAL LOT # 06061210. 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.

    Description of Event or Problem · 1

    A 3.2 MM FEMORAL AND TIBIAL BONE PIN TIP BROKE OFF IN THE PT. IT WAS APPROXIMATELY THE LAST 1 MM THAT BROKE. THE TIBIAL PIN BROKE DURING INSERTION, WHEN THE SURGEON WAS TRYING TO CONTINUE DRILLING IT IN AND THE PIN WOULDN'T GO FURTHER, HE REALIZED WHEN HE PULLED THE PIN OUT IT WAS BROKEN. THE FEMORAL PIN WAS NOTICED AFTER EXTRACTION.

    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 06051210

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR