BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT

    MDR report key: 9994112 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00759
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    December 7, 2018
    Report Date
    August 10, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE NAVIO HANDPIECE, INTENDED FOR USE IN TREATMENT, HAD A BROKEN SCREW PRIOR TO A PROCEDURE ON (B)(6) 2018. THERE WAS NO IMPACT ON THE CASE AND THERE WAS AN EQUIPMENT SWAP TO COMPLETE THE CASE. THE DEVICE WAS NOT BEING USED ON A PATIENT DURING THE REPORTED EVENT AND NO INJURIES WERE REPORTED. A DEVICE HISTORY RECORD REVIEW FOUND NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT AND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS DURING RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS. THE NAVIO HANDPIECE WAS RETURNED FOR FURTHER EVALUATION AND THE INITIAL VISUAL/FUNCTIONAL INSPECTION WAS PERFORMED, WHICH CONFIRMED THE REPORTED EVENT. THE SNAP LOCK NUT HAD BECOME UNTHREADED FROM THE SNAP LOCK. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE SUPPLIER / RAW MATERIAL FAULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TECH STRIPED THE SCREW ON THE HANDPIECE; SCREW IS BROKEN IN THE HAND PIECE. THE DEVICE WAS NOT BEING USED WITH A PATIENT DURING THE EVENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE SNAPLOCK ASSEMBLY HAS INCORRECT DIMENSIONS, WHICH MAKES IT A REPORTABLE EVENT. THE INCIDENT WITH THE THUMBSCREW WAS BEEN ADDRESSED UNDER FIELD REPORT 18-0757.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452716 HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1