BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996837 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00208
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    July 6, 2015
    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

    H10: THE DEVICE, USED IN TREATMENT, WAS 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 ANIDENTIFIED FAILURE MODE WITHIN THE RISK FILE. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD BE ESTABLISHED. FUNCTIONAL INVESTIGATION CONFIRMED THAT THE TEST OF THE BENT DRILL GUIDE SUPPORT MAKES IT MORE DIFFICULT FOR A DRILL/LONG ATTACHMENT COMBINATION TO BE INSERTED FULLY INTO THE SNAPLOCK. ADDITIONALLY, THE RETURNED DRILL THAT WAS USED DURING THE ERROR HAS A POSITIVE STOP THAT IS MORE BIASED IN THE CLOCKWISE DIRECTION. THEREFORE, IT REACHED THE COUNTER-CLOCKWISE STOP EARLIER THAN MOST DRILLS AND MAKES IT MORE SUSCEPTIBLE TO ROTATING OUT OF THE HANDPIECE DURING USE. THE MALFUNCTION IS LIKELY DUE TO MECHANICAL COMPONENT FAILURE FROM BENDING OF THE HANDPIECE DRILL GUIDE SUPPORT. THE MATERIAL HAS BEEN CHANGED TO STAINLESS STEEL TO INCREASE DURABILITY AND REDUCE DEFORMATION IN THE FIELD. PER COMPLAINT DETAILS, THE DEVICE MALFUNCTIONED DURING USE AND THE NAVIO WAS ABANDONED FOR MANUAL INSTRUMENTATION. BASED ON THE INFORMATION PROVIDED THE IMPACT BEYOND THE REPORTED MODIFIED PROCEDURE AND EXTENDED SURGICAL TIME COULD NOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL FALLING OUT OF THE HANDPIECE. THE DRILL WAS REINSERTED AND THE CASE CONTINUED. FOLLOWING CUTTING THE CUT SURFACE WAS BUMPY AND IRREGULAR AND DID NOT FOLLOW THE PLANNED IMAGE. THE SURGEON CHOOSE TO CUT THE FEMORAL SURFACE MANUALLY WITH THE BUR TAKEN OFF CONTROL IN LIEU OF REGENERATING THE BONE MODEL AND CUTTING WITH CONTROL. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DRILL GUIDE SUPPORT ON THE HANDPIECE WAS BENT, WHICH MAKES IT THE ROOT CAUSE OF THE DEVICE MALFUNCTION. PATIENT INJURIES WERE NOT REPORTED BEYOND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462142 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR