BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 8020240 · Received October 30, 2018

    Report

    Report Number
    3005985723-2018-00634
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 22, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486002923
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: PELVIC ARRAY SCREW BROKE OFF. SURGICAL DELAY =15 MINUTES. CASE TYPE: THA. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION SHOWS THE THUMB SCREW FRACTURED AND SEPARATED FROM THE REST OF THE ARRAY ASSEMBLY. THERE WAS APPARENT 'NECKING' IN AN AREA BETWEEN THE THREADS AND TIGHTENING FEATURE. FAILURE MODE CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED SINCE VISUAL INSPECTION CONFIRMED THE FRACTURED THUMB SCREW. MATERIAL ANALYSIS: THE MATERIAL WAS CONFIRMED DURING RECEIVING INSPECTION. ADDITIONAL MATERIAL ANALYSIS WAS NOT COMPLETED. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE FAILURE MODE WAS CONFIRMED DURING VISUAL INSPECTION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT NO 1945616 AND ACCEPTED INTO FINAL STOCK ON 10/01/2016. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 112230, LOT 19450616 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE PRS ARE (B)(4). CONCLUSIONS: VISUAL INSPECTION CONFIRMED THE FRACTURED THUMB SCREW. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    PELVIC ARRAY SCREW BROKE OFF. SURGICAL DELAY =15 MINUTES. CASE TYPE: THA.

    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

    PELVIC ARRAY SCREW BROKE OFF. SURGICAL DELAY - =15 MINUTES. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859306 PELVIC ARRAY ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19450616 00848486002923

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization