BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 4741064 · Received April 30, 2015

    Report

    Report Number
    3005985723-2015-00058
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    January 16, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: EVENT REPORTED ANSPACH MOTOR OVERHEATING AND SHUTTING OFF DURING SURGERY. THERE WAS NO HARM TO PATIENT OR USER. THE REPORTED 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 OF P/N 110940 S/N (B)(4). CONCLUSIONS: THE ANSPACH MOTOR IS AN OEM DEVICE. UPON RECEIPT, THE DEVICE WAS EVALUATED PER (B)(4) ANSPACH EMAX 2 PLUS BURR MOTOR AND THE REPORTED EVENT WAS CONFIRMED.

    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) IMPLANTS. DURING THE CASE, THE BURR MOTOR OVERHEATED AND SHUTDOWN. THE BACKUP BURR MOTOR WAS ALSO UNAVAILABLE DURING THE SAME CASE.

    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) IMPLANTS. DURING THE CASE, THE BURR MOTOR OVERHEATED AND SHUTDOWN. THE BACKUP BURR MOTOR WAS ALSO UNAVAILABLE DURING THE SAME CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285732 ANSPACH EMAX 2 PLUS BURR MOTOR STEROTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other