BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RI ROBOTIC DRILL ATTACHMENT

    MDR report key: 12443421 · Received September 8, 2021

    Report

    Report Number
    3010266064-2021-00626
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    May 24, 2021
    Report Date
    September 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORI DRILL ATTACHMENT, P/N ROB10015, SN (B)(4), INTENDED FOR USE IN TREATMENT WAS RETURNED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. THE REPORTED PROBLEM WAS VISUALLY AND FUNCTIONALLY CONFIRMED. THE DRILL ATTACHMENT WAS RECEIVED STILL CONNECTED TO THE COMPLAINT DRILL. THE DRILL WAS OPENED UP AND TAKEN APART. IT WAS FOUND THAT THE DRILL ATTACHMENT LOCK NUT IS OUT OF TORQUE SPECIFICATION. THE LOCK NUT BACKED ITSELF OUT CAUSING IT TO GET STUCK IN THE NOSEPIECE OF THE DRILL AND NOT BE ABLE TO BE DETACHED FROM THE DRILL. THE LOCKING NUT WAS PROPERLY TORQUED AND A KPC TEST WAS PERFORMED AND PASSED. 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 EVENT IS THE MECHANICAL LOCK NUT BECAME LOOSE DUE TO VIBRATION. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SET UP FOR A CORI LAB, THE REAL INTELLIGENCE ROBOTIC DRILL WAS ALREADY ASSEMBLED AND THE RI ROBOTIC DRILL ATTACHMENT WAS LOCKED ONTO THE DRILL AND WAS NOT ABLE TO REMOVE THE ATTACHMENT (CASE (B)(4) AND CASE (B)(4)). THE LAB WAS COMPLETED USING A S+N BACK-UP DEVICES. NO PATIENT WAS INVOLVED. MOREOVER, WHEN EVALUATING THE DRILL ATTACHMENT, IT WAS FOUND NUT TORQUE WAS LESS THAN REQUIRED (20"LBS). THE DRILL NUT BACKED OUT DURING USE FROM VIBRATION CAUSING THE DRILL ATTACHMENT TO LOCK ON THE NOSE PIECE OF THE DRILL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340477 RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10015 00885556757345

    Patients

    Seq Age Sex Outcome Treatment
    1