BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 16924301 · Received May 12, 2023

    Report

    Report Number
    3010266064-2023-00087
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION RECEIVED BY SMITH AND NEPHEW HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT BRAIN LAB IS THE LEGAL MANUFACTURER OF THE COMPLAINT DEVICE. THEREFORE, THIS EVENT WILL BE ROUTED TO BRAIN LAB FOR FURTHER REVIEW AND EVENT REPORTABILITY. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT INVOLVING A SMITH AND NEPHEW DEVICE, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT WILL BE SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, UPON CLICKING POINTER REMOTE FOR FINAL LEG LENGTH/OFFSET POSITION FUNCTION, LEG WAS IN THE GREEN BUT WHEN PRESSING THE BUTTON TO EXECUTE THE FUNCTION, AN ERROR WAS GIVEN. WHEN CLICKING ON ERROR IT INDICATED THAT THE DISTANCE WAS TOO LARGE, GREATER THAN 30 MM. AT THIS POINT, CORIS USAGE WAS PULLED BY THE SURGEON. UPON REVIEW OF THE CASE AND SPEAKING TO AN ENGINEER, THEY MENTIONED THAT THE CUP REGISTRATION ERROR WAS PROBABLY THE CASE. WHEN REGISTERING POINTS OF THE LUNATE SURFACE OF THE ACETABULUM, THE SURGEON WAS HAVING EXTREME DIFFICULTY IN GETTING THE CAMERA TO PICKUP THE PROBE POSTERIORLY AND MAPPED BAD POINTS DESPITE SUCCESSFULLY MAPPING. AFTER INITIAL REGISTRATION, THE CUP NAVIGATION FUNCTION TEMPLATED THE CUP TO BE A 44MM SHELL GIVING UNCERTAINTY BECAUSE THE TEMPLATE OFF X-RAY WAS 54MM. IN THE INTEREST OF SPEED, THE SURGEON DECIDED TO PROCEED WITH THE REGISTERED POINTS FOR A 44MM TEMPLATE AND JUST REAM UP TO AROUND A 54MM SHELL AND STILL USE LEG LENGTH AND CUP NAVIGATION. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032510 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown