BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKOPLASTY® PARTIAL KNEE END EFFECTOR

    MDR report key: 6552669 · Received May 8, 2017

    Report

    Report Number
    3005985723-2017-00202
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    May 2, 2017
    Report Date
    July 9, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE EVENT REPORTED THAT A PARTIAL KNEE END EFFECTOR WAS MISSING ITS TRIGGER MAGNET. DEVICE EVALUATION AND RESULTS: UNABLE TO PERFORM AS THE PRODUCT WAS NOT AVAILABLE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE FOLLOWING: (B)(4). QT 16-03-0076 DISPOSITIONED THE REJECTED PART AS RTV FOR WORKMANSHIP/DAMAGE. THE REJECTED PART WAS NOT THIS PART AND THE NONCONFORMANCE WAS UNRELATED TO THE ALLEGED FAILURE IN THIS INVESTIGATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 111758, L/N 19330515 SHOWS TEN (10) COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE (B)(4). CONCLUSION: THE FAILURE MODE WAS CONFIRMED. MATERIAL ANALYSIS WAS PERFORMED ON OTHER DEVICES OF THE SAME PART NUMBER AND LOT AND RESULTS SHOWED THE PARTS HAD NO ADHESIVE REMAINS AT THE SIDEWALLS OF THE CAVITY AND VERY LITTLE REMNANTS AT THE BASE OF THE CAVITY FOR THOSE DEVICES THAT WERE UNDERWENT MAGNET DISASSOCIATION OR LOOSENING. CORRECTIVE ACTION / PREVENTIVE ACTION: (B)(4) HAS BEEN CLOSED FOR THE FAILURE MODE OF MAGNET DISASSOCIATION EXCEEDING THE ACCEPTABLE OCCURRENCE RATE. CAPA (B)(4) HAS BEEN INITIATED FOR THE FAILURE MODE.

    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

    END EFFECTOR ASSEMBLY IS MISSING MAGNET IN ITS TRIGGER NECESSARY TO ACTIVATE BURR MOTOR.

    Description of Event or Problem · 1

    END EFFECTOR ASSEMBLY IS MISSING MAGNET IN ITS TRIGGER NECESSARY TO ACTIVATE BURR MOTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332675 MAKOPLASTY® PARTIAL KNEE END EFFECTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization