BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6649975 · Received June 19, 2017

    Report

    Report Number
    3005985723-2017-00252
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    June 15, 2017
    Report Date
    August 10, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: ONE OF THE END EFFECTORS HAS THE BACK ENGAGEMENT KNOB BROKEN OFF. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. VARIOUS DING MARKS ARE SEEN ON THE 206997 HIP END EFFECTOR BASE. 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. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 15 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09/25/2014 INCLUDING SERIAL NUMBER (B)(4) COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT 19090214 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. PR 1089260 AND 1141795 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

    ONE OF THE END EFFECTORS HAS THE BACK ENGAGEMENT KNOB BROKEN OFF. THE IMPACTION PLATFORM IS STUCK ON THE IMPACTOR SHAFT WHICH IS INSIDE THE OTHER END EFFECTORS THEREFORE WE CAN'T TAKE THE PIECE APART AND EFFECTIVELY USE. WE WILL ALSO NEED AN INLINE OFFSET IMPACTOR SHAFT AS WE HAVE OURS STUCK INSIDE THE END EFFECTOR DUE TO THE IMPACTION PLATFORM BEING STUCK ON AND UNABLE TO TAKE APART.

    Description of Event or Problem · 1

    ONE OF THE END EFFECTORS HAS THE BACK ENGAGEMENT KNOB BROKEN OFF. THE IMPACTION PLATFORM IS STUCK ON THE IMPACTOR SHAFT WHICH IS INSIDE THE OTHER END EFFECTORS THEREFORE WE CAN'T TAKE THE PIECE APART AND EFFECTIVELY USE. WE WILL ALSO NEED AN INLINE OFFSET IMPACTOR SHAFT AS WE HAVE OURS STUCK INSIDE THE END EFFECTOR DUE TO THE IMPACTION PLATFORM BEING STUCK ON AND UNABLE TO TAKE APART. IMPOSSIBLE FOR ME TO SEE THE SERIAL NUMBER AS THE PART IS INSIDE EE. TYPE OF CASE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430082 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19090214

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization