BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RI ROBOTIC DRILL ATTACHMENT

    MDR report key: 10564587 · Received September 21, 2020

    Report

    Report Number
    3010266064-2020-01785
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 26, 2020
    Report Date
    April 8, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757345
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORI DRILL ATTACHMENT INTENDED FOR USE IN TREATMENT WAS RETURNED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. A KPC TEST WAS RUN AND THE TEST PASSED. THE REPORTED PROBLEM WAS CONFIRMED. THE DRILL ATTACHMENT WAS HOT TO THE TOUCH DURING AND AFTER TESTING. THE DRILL ATTACHMENT SHAFT WAS OPENED AND IT WAS FOUND THAT THERE WAS DEBRIS ON THE LOWER BEARING. THE DEBRIS WAS REMOVED AND THE TEST WAS RUN AGAIN WITHOUT ANY ISSUES. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. THE MOST LIKELY CAUSE OF THIS ISSUE WAS THAT DEBRIS GOT BEHIND THE DRILL ATTACHMENT WIPER AND INTO THE BEARING SHAFT. BASED ON THE INVESTIGATION, NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPLACING BOTH THE CAMERA AND THE CORI CONSOLE, CORI SAWBONE LAB/DEMO WAS PLANNED AND THE LONG ATTACHMENTS WERE CHECKED RESPECTIVELY WITH A BUR. THE BUR WAS INSERTED IN THE LONG ATTACHMENT TO SEE THE RESISTANCE PRESENTED TO THE BUR, AND THREE LONG ATTACHMENTS PRESENTED RESISTANCE. THE BEARINGS WITHIN THE ATTACHMENTS COULD HAVE AN EXCESS OF EPOXY LIKELY CREATING FRICTION WHEN SPINNING THE BUR WHICH CAN ALSO CREATE HEAT. THIS EXPLAINS WHY SOME OF THE BUR ATTACHMENTS ARE MUCH HOTTER THAN OTHERS WHILE BURRING. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028867 RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10015 00885556757345

    Patients

    Seq Age Sex Outcome Treatment
    1