BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 3941119 · Received April 25, 2014

    Report

    Report Number
    3005985723-2014-00046
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED AT MAKO SURGICAL. THE AVAILABLE PIN WAS NOT RETAINED FOR THE INVESTIGATION. IT WAS DISCARDED AT THE END OF THE CASE. THE REMAINDER OF THE PIN COULD NOT BE REMOVED FROM THE PATIENT BECAUSE THE BROKEN PIECE OF THE PIN WAS BELOW THE SURFACE OF THE BONE. THE FAILURE IN THIS COMPLAINT IS ATTRIBUTED TO PATIENT HARD BONE AND THE USER NOT FOLLOWING RECOMMENDED TECHNIQUE BY REDIRECTING THE PIN OFF-AXIS UPON INSERTION. THIS MDR IS BEING FILED BECAUSE OF THE BONE PIN BREAKAGE AND BECAUSE THE BONE PIN IS ALSO CURRENTLY AVAILABLE FOR USE IN THE SAME MANNER AS WITH THE RIO FOR PARTIAL KNEE ARTHROPLASTY UNDER K112507.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE KINETIS CR TOTAL KNEE IMPLANT SYSTEM AS PART OF AN IDE STUDY ((B)(4)). ON A POST-OPERATIVE X-RAY, THE SURGEON NOTICED THAT A BONE PIN TIP BROKE OFF DURING INSERTION INTO THE TIBIA. THE SURGEON DECIDED TO LEAVE THE BONE PIN TIP IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250784 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTAXIC DEVICE NPJ MAKO SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 KINETIS CR TOTAL KNEE IMPLANT SYSTEM