BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 7099965 · Received December 8, 2017

    Report

    Report Number
    3005985723-2017-00619
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 28, 2017
    Report Date
    February 6, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: BEFORE THE CASE, THE REAMER HAD A HARD TIME GETTING IN AND OUT OF THE END EFFECTOR. AFTER THE CASE, WE NOTICED A SPRING CAME OUT OF THE END EFFECTOR. THA CASE. DEVICE 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 THE 202857 DOWEL PIN THAT LOCATES THE 202870 HIP CHUCK SLIDE ASSEMBLY IS SITTING PROUD ON THE SURFACE, THE 202870 HIP CHUCK ASSEMBLY IS ABLE TO FREELY ROTATE DUE TO THE 202857 PIN MOVING OUTWARDS. VISUAL INSPECTION SHOWS FRACTURE AT THE DEGREE MARKERS OF THE 206966 REAMER BARREL. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION AS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 11/28/2016. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967 , LOT NUMBER 19530615 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.

    Description of Event or Problem · 0

    BEFORE THE CASE, THE REAMER HAD A HARD TIME GETTING IN AND OUT OF THE END EFFECTOR. AFTER THE CASE, WE NOTICED A SPRING CAME OUT OF THE END EFFECTOR. THA CASE.

    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

    BEFORE THE CASE, THE REAMER HAD A HARD TIME GETTING IN AND OUT OF THE END EFFECTOR. AFTER THE CASE, WE NOTICED A SPRING CAME OUT OF THE END EFFECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878162 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization