BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM - RIO

    MDR report key: 2531715 · Received March 28, 2012

    Report

    Report Number
    3005985723-2012-00015
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U AN INVESTIGATION WAS PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO). THE RESULTS OF THE INVESTIGATION REVEALED THAT THE ROOT CAUSE FOR THE DEEPER CUT IN THE TIBIA WAS DUE TO IMPROPER ENGAGEMENT OF THE BURR IN THE BURR MOTOR OF THE 3RD PARTY DRILL SYSTEM USED WITH THE RIO.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2012. AFTER CUTTING A PORTION OF THE TIBIA, THE SURGEON OBSERVED THAT THE CUT WAS DEEPER THAN PLANNED. THE SURGEON DETERMINED THAT THE PROPER COURSE OF ACTION WAS TO COMPLETE THE PROCEDURE USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND SURGEON WAS SATISFIED WITH THE OUTCOME OF THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR