BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 5074972 · Received September 14, 2015

    Report

    Report Number
    3005985723-2015-00159
    Event Type
    Malfunction
    Date Received
    September 14, 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

    BASED ON RESULTS OF INVESTIGATION. REPORTED EVENT: THE REPORTED EVENT WAS A NON-FUNCTIONING ANSPACH MOTOR P/N 110940, S/N (B)(4). METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS INSPECTED AND THE FAILURE MODE WAS CONFIRMED. THE DEVICE OVERHEATING AND MADE AUDIBLE NOISE. 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). NO OTHER COMPLAINTS WERE FOUND. CONCLUSIONS: THE ANSPACH MOTOR IS AN OEM DEVICE. THE DEVICE WAS RETURNED TO THE SUPPLIER AFTER CONFIRMATION OF THE FAILURE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE THE ANSPACH BURR MOTOR MALFUNCTIONED. THE ANSPACH MOTOR WAS EXCHANGED WITH A REPLACEMENT ANSPACH MOTOR, WHICH THEN ALSO MALFUNCTIONED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE THE ANSPACH BURR MOTOR MALFUNCTIONED. THE ANSPACH MOTOR WAS EXCHANGED WITH A REPLACEMENT ANSPACH MOTOR, WHICH THEN ALSO MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605611 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other