BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 4321847 · Received November 26, 2014

    Report

    Report Number
    3005985723-2014-00195
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AND EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS A SUPPLEMENTAL REPORT TO THE ORIGINAL MDR SUBMITTED PREVIOUSLY. ADDITIONAL INFORMATION REGARDING THE EVENT IS PROVIDED HEREIN. THE MALFUNCTION WAS ATTRIBUTED TO; FAILURE TO PROPERLY UPDATE RIO HARDRIVE DURING SITE INSTALLATION, MOTION ROD FAILURE CAUSED BY ERROR IN CT SCAN PROTOCOL (MOTION ROD NOT BEING CAPTURED PROPERLY IN THE CT FIELD OF VIEW (FOV) RESULTED IN FAILURE OF AUTOMATED WORKFLOW AND REQUIRING MANUAL WORKFLOW FOR PATIENT PLAN CREATION), UNRESOLVED MOTION ROD FAILURE, INCORRECT SELECTION OF PATIENT CT SCAN, AND INCORRECT CONFIRMATION OF PATIENT TIMEOUT. PATIENT NAME AND PATIENT ID BASED ON CT SCAN INFORMATION ARE DISPLAYED IN THE STRYKER-MAKO APPLICATION ON THE PATIENT TIMEOUT TO CONFIRM CORRECT PATIENT PLAN. MISIDENTIFICATION OF PATIENT TIMEOUT RESULTED IN INITIATION OF SURGICAL INCISION ON PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT. THE RIO AND RETORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS COULD NOT BE UTILIZED IN THE SURGERY BECAUSE AN INCORRECT PATIENT SOFTWARE FILE WAS SENT AND THUS THE SURGEON DID NOT HAVE THE INFO NECESSARY TO COMPLETE THE PROCEDURE AS PLANNED. THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769454 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. 204000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention