BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6476946 · Received April 10, 2017

    Report

    Report Number
    3005985723-2017-00170
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    April 5, 2017
    Report Date
    May 22, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: SILVER LOCKING HANDLE AT BACK OF END EFFECTOR BROKE OFF DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. REFERENCE ATTACHED IMAGES. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 08/30/2016 INCLUDING SERIAL NUMBER (B)(4). COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT 19410515 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: ALLEGED FAILURE CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA (B)(4) WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    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

    THE SURGEON COMPLETED A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. AT THE END OF THE CASE, IT WAS NOTICED THAT THE SILVER LOCKING HANDLE AT BACK OF END EFFECTOR BROKE OFF. THE MPS IS NOT SURE AT WHAT POINT THE HANDLE BROKE OFF.

    Description of Event or Problem · 1

    THE SURGEON COMPLETED A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. AT THE END OF THE CASE, IT WAS NOTICED THAT THE SILVER LOCKING HANDLE AT BACK OF END EFFECTOR BROKE OFF. THE MPS IS NOT SURE AT WHAT POINT THE HANDLE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256682 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization