BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 3170413 · Received May 24, 2013

    Report

    Report Number
    3005985723-2013-00030
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE EVENT WAS INITIATED AT MAKO SURGICAL. NO PRELIMINARY RESULTS ARE CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE SURGEON BEGAN BURRING ON THE ANTERIOR TIP OF THE FEMUR. HE BURRED APPROXIMATELY 1/10 OF THE FEMUR WHEN HE DID HIS USUAL CT VIEW CHECK WITH THE GREEN PROBE. THE CHECK WITH THE PROBE AND A VISUAL CHECK, REVEALED A 6 TO 8 MM DEEP "HOLE" ON THE ANTERIOR LATERAL TIP OF THE FEMORAL RESECTION. THE SURGEON "TUGGED" THE BURR AND IT RELEASED (WITHOUT USING THE RELEASE MECHANISM). A BACKUP MOTOR AND BURR WERE SETUP AND USED TO COMPLETE THE CASE. THE 6 MM TO 8 MM HOLE WAS FILLED WITH BONE CEMENT AND THE CASE CONCLUDED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231680 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR