BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 5138084 · Received October 8, 2015

    Report

    Report Number
    3005985723-2015-00183
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 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: INSPECTED PER TSP-0011 EMAX 2 ANSPACH MADE LOUD SQUEALING NOISE STARTED TO OVERHEAT AND SMOKED. RETURN TO VENDOR 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 LOCKING MECHANISM FAILURE OF P/N 110940 S/N(B)(4). THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER. 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.

    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.

    Description of Event or Problem · 1

    THE SURGEON WAS SCHEDULED TO PERFORM A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). PRIOR TO THE CASE DURING SYSTEM CHECK THE BURR MOTOR BEGAN SMOKING.

    Description of Event or Problem · 1

    THE SURGEON WAS SCHEDULED TO PERFORM A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). PRIOR TO THE CASE DURING SYSTEM CHECK THE BURR MOTOR BEGAN SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668564 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other