BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 140MM

    MDR report key: 2571024 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00116
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    MAKO SURGICAL
    Product Code
    JDW
    PMA / PMN Number
    K081867
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BONE PINS BENDS OCCUR OCCASIONALLY, AND BONE PIN BREAKS OCCUR RARELY; BOTH ARE KNOWN ISSUES OF ORTHOPEDIC PROCEDURES. TIPS OF DRILLS AND BONE PINS ARE FREQUENTLY LEFT IN PTS AND ARE CONSIDERED LOW RISK BY THE SURGEON. MAKO BONE PINS ARE SOLD IN BOTH 3.2MM AND 4.0MM DIAMETERS OF VARYING LENGTHS. (B)(4). AVAILABLE HISTORICAL DATA ON BONE PIN BREAKAGE WERE ANALYZED FOR THIS INVESTIGATION. SURGEONS WERE ALSO SURVEYED FOR INSIGHT ON THE ISSUE. THE ANALYSES SHOW THE MAJOR CONTRIBUTING FACTOR TO BONE PIN BREAKAGE ARE: SURGICAL TECHNIQUE, PT SELECTION, FAILURE TO USE A DRILL GUIDE, AND USING A DRILL SPEED THAT IS TOO SLOW THEREBY INCREASING TORQUE ON THE BONE PIN. SURGEONS DID NOT EXPRESS CONCERNS ABOUT THE RATE OF BONE PIN BREAKAGE ASSOCIATED WITH MAKOPLASTY CASES. ADD'L MODEL #: 111670.

    Description of Event or Problem · 1

    A BONE PIN BROKE UPON INSERTION INTO THE BONE DURING A MAKOPLASTY KNEE ARTHROPLASTY CASE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1