BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 9362260 · Received November 22, 2019

    Report

    Report Number
    3005985723-2019-00837
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    September 16, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022167
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT END EFFECTOR COLLAR BROKE OFF. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION. VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM. A RING CAN BE SEEN ON THE BACK OF THE 202866 RELEASE KNOB. THE 202866 RELEASE KNOB IS SHEARED OFF. THERE IS OXIDATION AND DISCOLORATION ON THE 202870 SLIDE ASSEMBLY, 202862 BALL RETAINER. THE 206966 REAMER BARREL HAS FRACTURES/CRACKS AT THE DEGREE MARKERS . THERE ARE DAMAGED MARKS ON THE BASE OF THE END EFFECTOR. 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 AS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS COMPLETED AS PART OF THE ROOT CAUSE INVESTIGATION OF CAPA PRODUCT HISTORY REVIEW: "REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED UNDER LOT 19410515 AND 38 ACCEPTED INTO FINAL STOCK ON 08/30/2016. REVIEW OF QT16-08-0108 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 19410515 SHOWS 18 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE IS CONFIRMED VIA VISUAL INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    END EFFECTOR COLLAR BROKE OFF. CASE TYPE: THA. PATIENT WAS UNDER ANESTHESIA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    END EFFECTOR COLLAR BROKE OFF. CASE TYPE: THA. PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155217 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19410515/ 1901070 00848486022167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization