BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 4528939 · Received February 19, 2015

    Report

    Report Number
    3005985723-2015-00018
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    December 22, 2014
    Report Date
    January 20, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: ANSPACH EMAX 2 PLUS BURR MOTOR SMOKES AND HAS LOSS OF POWER. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE ANSPACH EMAX 2 PLUS BURR MOTOR EVENT WAS CONFIRMED. -DEVICE HISTORY REVIEW: NOT PERFORMED AS THE ANSPACH EMAX 2 PLUS BURR MOTOR IS AN OEM PRODUCT. -COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING OVERHEATING FAILURE OF P/N 110940 S/N: (B)(4). THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER. TREND REQUEST FOR THIS PART NUMBER HAS BEEN SUBMITTED (TREND REQUEST #737). CONCLUSIONS: THE ANSPACH EMAX 2 PLUS BURR MOTOR IS AN OEM DEVICE. UPON RECEIPT, THE DEVICE WAS EVALUATED PER TSP-0011 ANSPACH EMAX 2 PLUS BURR MOTOR AND THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. EVALUATION OF THE RETURNED MOTORS IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL RESULTS ARE OBTAINED.

    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 BEGAN SMOKING AND LOST POWER.

    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 BEGAN SMOKING AND LOST POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119462 ANSPACH EMAX 2 PLUS BURR MOTOR STEROTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other