BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARRAY

    MDR report key: 8858171 · Received August 2, 2019

    Report

    Report Number
    3005985723-2019-00546
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 18, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486015923
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT "DURING A MAKO TKA THE SURGEON HAD DIFFICULT MAINTAINING A REGISTRATION ON THE TIBIA AND FEMUR. ON INSPECTION THE ARRAY ITSELF WAS WOBBLY AT THE CENTRE ATTACHMENT." THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES 100 DEVICE(S) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 14MAY2018 WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112280, LOT 19160218 SHOWS 00 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE PRODUCT WAS NOT RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO CONFIRMED FAILURE MODE. H3 OTHER TEXT : PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    DURING A MAKO TKA THE SURGEON HAD DIFFICULT MAINTAINING A REGISTRATION ON THE TIBIA AND FEMUR. ON INSPECTION THE ARRAY ITSELF WAS WOBBLY AT THE CENTRE ATTACHMENT. SURGICAL DELAY OF APPROXIMATELY 1 HOUR.

    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

    DURING A MAKO TKA THE SURGEON HAD DIFFICULT MAINTAINING A REGISTRATION ON THE TIBIA AND FEMUR. ON INSPECTION THE ARRAY ITSELF WAS WOBBLY AT THE CENTRE ATTACHMENT. SURGICAL DELAY OF APPROXIMATELY 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650016 TIBIAL ARRAY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19160218 00848486015923

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization