BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9994117 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00114
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    December 6, 2013
    Report Date
    August 25, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED IN TREATMENT AND IT WAS REPORTED THAT NAVIO SYSTEM DISPLAYED EXPOSURE CONTROL MOTOR ERROR WHEN ENTERING CUT MODE. DHR REVIEW FOUND THAT NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT WERE IDENTIFIED. THIS INFORMATION IS REASONABLY SUGGESTING THAT THE DEVICE MET THE SPECIFICATIONS AT THE DATE WHEN IT WAS RELEASED TO THE DISTRIBUTION. A COMPLAINT HISTORY FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. AFTER THE INSTRUCTIONS FOR USE REVIEW, PRODUCT LABELING HAS BEEN RULED OUT AS A CAUSE OF THE COMPLAINT. THIS IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK ASSESSMENT. WE COULD CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. THE DEVICE WAS INVESTIGATED AND IT WAS FOUND THAT THE CONNECTION WAS TIGHT DUE TO INSUFFICIENT LUBRICATION. SPRAYING LUBRICANT ON THE HANDPIECE PRIOR TO STERILIZATION CAN REDUCE ISSUES FROM SEPARATING THE DRILL FROM THE HANDPIECE. THE ROOT CAUSE WAS ESTABLISHED TO BE UNDETERMINED AFTER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BURR SIZE WAS UNABLE TO BE CHANGED BECAUSE WAS NOT POSSIBLE TO UNCLIP THE ANSPACH DRILL FROM THE HANDPIECE. THE SURGEON HAD TO CUT THE KEEL IN MANUAL MODE USING A 5MM BURR. AFTER THE CASE, BOTH PARTS WERE SEPARATED BUT THE CONNECTION WAS VERY TIGHT BETWEEN THE HANDPIECE AND THE LONG ATTACHMENT. PATIENT INJURIES WERE NOT REPORTED BEYOND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452720 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PN 110006 / ANSPACH LONG ATTACHMENT| PN 110006 / ANSPACH LONG ATTACHMENT