BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6826675 · Received August 29, 2017

    Report

    Report Number
    3005985723-2017-00402
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 25, 2017
    Report Date
    December 19, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: IT WAS REPORTED THAT THE HIP END EFFECTOR WAS FOUND BROKEN AFTER THA CASE. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION. VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM WITH BALL BEARINGS FAILING. DISCOLORATION AND WEAR ARE SEEN ON THE 202862 HIP BALL RETAINER. VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. SEE ATTACHMENTS FOR IMAGES OF THE INSTRUMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4).. A REVIEW OF QT17 - 04 - 0055 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT NUMBER 19430816 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: ALLEGED FAILURE CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA (B)(4) WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    Description of Event or Problem · 1

    AFTER IMPACTING THE CUP IT WAS DISCOVERED THAT THE END EFFECTOR WAS BROKE ON THE BACK END. CASE TYPE THA.

    Description of Event or Problem · 1

    AFTER IMPACTING THE CUP IT WAS DISCOVERED THAT THE END EFFECTOR WAS BROKE ON THE BACK END. CASE TYPE THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607983 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization