BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 5055373 · Received September 3, 2015

    Report

    Report Number
    3005985723-2015-00156
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 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

    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

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A ANSPACH MOTOR, P/N 110940, S/N (B)(4), RMA (B)(4). DEVICE EVALUATION AND RESULTS: PER GSP CASE (B)(4(, THE DEVICE WAS INSPECTED IN ACCORDANCE WITH (B)(4) ANSPACH EMAX 2 PLUS BURR MOTOR. THE DEVICE MADE A LOUD SQUEALING NOISE, STARTED TO OVERHEAT, AND SMOKED. DEVICE HISTORY REVIEW: DHR REVIEW WAS NOT PERFORMED AS THIS IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 110940, SERIAL NUMBER (B)(4) FOUND NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 110940 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST # (B)(4). CONCLUSIONS: THE FAILURE WAS CONFIRMED BY INVESTIGATION.

    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 ANSPACH BURR MOTOR MALFUNCTIONED. THE ANSPACH MOTOR WAS EXCHANGED WITH A REPLACEMENT ANSPACH MOTOR, WHICH THEN ALSO MALFUNCTIONED. THE MOTOR WAS EXCHANGED FOR A THIRD REPLACEMENT MOTOR . THE CASE WAS THEN COMPLETED SUCCESSFULLY.

    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 ANSPACH BURR MOTOR MALFUNCTIONED. THE ANSPACH MOTOR WAS EXCHANGED WITH A REPLACEMENT ANSPACH MOTOR, WHICH THEN ALSO MALFUNCTIONED. THE MOTOR WAS EXCHANGED FOR A THIRD REPLACEMENT MOTOR . THE CASE WAS THEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585712 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention