BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT

    MDR report key: 9995841 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00767
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    May 2, 2018
    Report Date
    August 21, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE NAVIO HANDPIECE, USED IN TREATMENT, WAS RETURN FOR EVALUATION. THE NAVIO HANDPIECE HAD A BROKEN SNAP LOCK NUT DURING A PROCEDURE ON (B)(6) 2018. THE INITIAL VISUAL/FUNCTIONAL INVESTIGATION CONFIRMED THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW FOUND NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT AND THE DEVICE MET ALL SPECIFICATIONS DURING RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS AND THIS ISSUE WILL CONTINUE TO BE MONITORED. THE NAVIO SURGICAL SYSTEM FOR UNICONDYLAR KNEE REPLACEMENT AND PATELLOFEMORAL ARTHROPLASTY USER'S MANUAL RELEASED AT THE TIME OF THE COMPLAINT PROVIDES NO INFORMATION REGARDING THE BROKEN SNAP LOCK NUT. THIS FAILURE IS CAPTURED IN THE NAVIO RISK PROFILE. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE DUE TO MECHANICAL COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UKR SURGERY, THE SNAPLOCK NUT ON THE HANDPIECE IS BROKEN. THE SURGERY WAS CONVERTED TO MANUAL TECHNIQUE. THE PATIENT OUTCOME IS UNKNOWN. THE RESULTS OF INVESTIGATION INDICATE THAT THE SNAPLOCK NUT WAS BROKEN, WHICH IS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460659 HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention