BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6761269 · Received August 2, 2017

    Report

    Report Number
    3005985723-2017-00352
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 19, 2017
    Report Date
    September 25, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AT END OF CASE, SILVER RELEASE HANDLE ON BACK OF END EFFECTOR WAS BROKEN OFF. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM WITH BALL BEARINGS FAILING. DISCOLORATION AND WEAR ARE SEEN ON THE FOLLOWING COMPONENTS: 202862 HIP BALL RETAINER, 202877 HIP RELEASE KNOB, 202870 HIP CHUCK SLIDE ASSEMBLY AND 202409 BALL BEARING. RUST CAN BE SEEN ON THE 202856 COMPRESSION SPRING. 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. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT NO 19380515 AND ACCEPTED INTO FINAL STOCK ON 07/07/2016. A REVIEW OF (B)(4) 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 19380515 SHOWS 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. PR (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

    AT END OF CASE, SILVER RELEASE HANDLE ON BACK OF END EFFECTOR WAS BROKEN OFF.

    Description of Event or Problem · 1

    AT END OF CASE, SILVER RELEASE HANDLE ON BACK OF END EFFECTOR WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541382 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19380515

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization