BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9994339 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00464
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    November 6, 2017
    Report Date
    August 26, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR INVESTIGATION. THE PROBABLE CAUSE OF THE ISSUE WAS A MECHANICAL COMPONENT FAILURE. 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 REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE SURGICAL TECHNIQUE GUIDE RELEASED AT THE TIME OF THE COMPLAINT PROVIDES INSTRUCTIONS FOR USING THE HANDPIECE. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE ESTABLISHED. NO VISUAL/FUNCTIONAL EVALUATION WAS CONDUCTED SINCE THE DEVICE WAS NOT RETURNED, BUT BASED UPON THE REPORTED EVENT DESCRIPTION, THIS FAILURE HAD BEEN PREVIOUSLY ATTRIBUTED TO A MECHANICAL COMPONENT FAILURE. A FACTOR THAT COULD HAVE CONTRIBUTED TO THIS EVENT IS IF THE DRILL GUIDE SUPPORT WAS ALUMINUM. THE MATERIAL HAS BEEN CHANGED TO STAINLESS STEEL TO INCREASE DURABILITY AND REDUCE DEFORMATION IN THE FIELD, WHERE A CORRECTIVE ACTION HAS BEEN OPEN FOR THIS ISSUE. HOWEVER, WITHOUT THE ACTUAL DEVICE OR PHOTOS FOR VISUAL INSPECTION TO CONFIRM THE COLOR OR MATERIAL OF THE DEVICE, THE ACTUAL CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. PER COMPLAINT DETAILS, THE DEVICE MALFUNCTIONED PRIOR TO SURGICAL USE. THE SURGEON CHANGED TO A MANUAL INSTRUMENTATION TO COMPLETE THE PROCEDURE. BASED ON THE INFORMATION PROVIDED, THERE WAS NO SURGICAL DELAY OR PATIENT INJURY/IMPACT TO THE PATIENT. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HOMING FAILURE WITH THE HANDPIECE; THE SURGICAL TECH HAD ISSUES ADVANCING THE DRILL WITH LONG ATTACHMENT INTO THE NAVIO HANDPIECE. THE SURGEON WAS READY FOR THE CASE BY THE TIME THEY OPENED THE THIRD NAVIO BUT THE THREE DEVICES FAILED, JUST ABORTED, AND DID A MANUAL. NO PATIENT INJURIES REPORTED BEYOND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458724 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention