BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 4938316 · Received July 24, 2015

    Report

    Report Number
    3005985723-2015-00136
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 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

    FOLLOW-UP #1 SUBMITTED TO CORRECT SECTION AND TO UPDATE SECTIONS BASED ON RESULTS OF INVESTIGATION. THE EVENT WAS CONFIRMED. REPORTED EVENT: AN ANSPACH EMAX 2 PLUS BURR MOTOR, CATALOG: 110940, SERIAL NUMBER: (B)(4), BEGAN MAKING LOUD NOISES DURING A CASE BUT WAS ABLE TO SUCCESSFULLY COMPLETE THE CASE WITHOUT DELAY. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE ANSPACH EMAX 2 PLUS BURR MOTOR FAILURE 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 S/N. 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). AFTER THE CASE, IT WAS NOTICED THAT THE BEARINGS WERE BROKEN AND SITTING INSIDE THE HD LONG ATTACHMENT. IT WAS ALSO NOTICED THAT THERE WAS SOME CONTAMINATION AT THE HD LONG ATTACHMENT AND BURR MOTOR LOCKING MECHANISM INTERFACE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER THE CASE, IT WAS NOICED THAT THE BEARINGS WERE BROKEN AND SITTING INSIDE THE HD LONG ATTACHMENT. IT WAS ALSO NOTICED THAT THERE WAS SOME CONTAMINATION AT THE HD LONG ATTACHMENT AND BURR MOTOR LOCKING MECHANISM INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484574 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other