BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 5383469 · Received January 21, 2016

    Report

    Report Number
    3005985723-2016-00039
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THIS DEVICE WAS DETERMINED NOT REPORTABLE AS STRYKER MAKO RECEIVED ADDITIONAL INFORMATION FROM THE SALES REPRESENTATIVE THAT THE TOTAL SURGICAL DELAY WAS OF 20 MINUTES.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A BILATERAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE BURR MOTOR LOST POWER WHILE BURRING THE TIBIA. THE ANSPACH MOTOR WAS REPLACED WITH A REPLACEMENT ANSPACH MOTOR WHICH THE SURGEON REPORTED LOW RPM. THE SECOND MOTOR OVERHEATED AND THERE WAS A DELAY OF 30 SECONDS WHILE WAITING FOR THE BURR TO COOL DOWN. THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A BILATERAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE BURR MOTOR LOST POWER WHILE BURRING THE TIBIA. THE ANSPACH MOTOR WAS REPLACED WITH A REPLACEMENT ANSPACH MOTOR WHICH THE SURGEON REPORTED LOW RPM. THE SECOND MOTOR OVERHEATED AND THERE WAS A DELAY OF 30 SECONDS WHILE WAITING FOR THE BURR TO COOL DOWN. THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42394 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTICE DEVICE, ACCESSORY OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other