BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 5292762 · Received December 14, 2015

    Report

    Report Number
    3005985723-2015-00295
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 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 WAS SMOKING AND REALLY HOT. 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 SMOKING AND GETTING REALLY HOT FAILURE OF P/N: 110940 S/N: (B)(4). THERE HAS BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER. TREND REQUEST #737 FOR THIS PART NUMBER HAS BEEN SUBMITTED. 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 BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A BILATERAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS NOTICED AFTER THE CASE, THE BURR MOTOR OVERHEATED AND BEGAN SMOKING.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A BILATERAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS NOTICED AFTER THE CASE, THE BURR MOTOR OVERHEATED AND BEGAN SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822453 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other