BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 4MM X 140MM

    MDR report key: 1173365 · Received September 19, 2008

    Report

    Report Number
    3005985723-2008-00008
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 20, 2008
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    JDW
    PMA / PMN Number
    K072806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BONE PIN INVOLVED WAS NOT RETURNED. THE RISK OF BONE PIN BREAKAGE IS NOT UNIQUE TO OUR PROCEDURE AND IS A WELL KNOWN AND ACCEPTED RISK IN COMPUTER-ASSISTED SURGERIES. INVESTIGATION IS ONGOING TO ENSURE FAILURE WAS NOT DUE TO MANUFACTURING OR MATERIAL DEFECT. IF RESULTS INDICATE A POTENTIAL FAILURE IN THESE ARMS, A "DEVICE EVAL" MDR WILL BE FILED.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN REMOVING THE BONE PINS, TWO OF THE PINS BENT NEAR OR AT THE THREADS AND WERE THUS DIFFICULT TO REMOVE. THE SURGEON RETRIEVED ANOTHER DEVICE TO SLIDE OVER THE PINS TO UNTHREAD THEM, HOWEVER, ONE OF THE BONE PINS BROKE. THE SURGEON CHOSE TO LEAVE A SMALL PIECE IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE PIN, 4MM X 140MM PIN, FIXATION, THREADED (JDW) JDW MAKO SURGICAL CORP. 0150TPN00200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability STELKAST UNI-KNEE SYSTEM