BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO LONG ATTACHMENT

    MDR report key: 13653875 · Received March 2, 2022

    Report

    Report Number
    3010266064-2022-00158
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 11, 2022
    Report Date
    May 2, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628607
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE NAVIO LONG ATTACHMENT, PFSR110006, S/N (B)(6), USED FOR TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. THE REPORTED PROBLEM WAS VISUALLY CONFIRMED. THE DISTAL TIP OF THE LONG ATTACHMENT IS BLUNT. THE MOST LIKELY CAUSE OF THE BLUNTED DISTAL TIP OF THE LONG ATTACHMENT IS PRODUCT MISHANDLING. REFER TO THE NAVIO SURGICAL SYSTEM INSTRUMENT KIT CLEANING AND STERILIZATION GUIDE FOR PROPER HANDLING. CARE AND CAUTION SHOULD BE EXERCISED DURING SETUP, USE, DECONTAMINATION, AND STERILIZATION. A FUNCTIONAL EVALUATION WAS PERFORMED. A BUR WAS INSERTED INTO THE LONG ATTACHMENT. THERE WAS NO RESISTANCE AND THE BUR WAS INSERTED WITH NO ISSUES. THE REPORTED PROBLEM WAS NOT CONFIRMED. CONTRIBUTING FACTORS ASSOCIATED WITH BUR INSERTION ARE POSSIBLE LONG ATTACHMENT BEARING WEAR. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THIS CASE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THEY WENT TO BUR THE FEMORAL CONDYLE DURING A NAVIO ASSISTED SURGERY, THE FIRST ANSPACH DRILL WOULDN'T SPIN (THE HANDPIECE MOVED THE DRILL FORWARD BUT THE DRILL WOULDN'T SPIN). THEY CHECKED THE SURGEON WAS PRESSING THE BLACK PEDAL AND WERE ON "CUT FEMUR", UNPLUGGED THE DRILL AND TRIED AGAIN BUT THE DRILL WOULDN'T WORK. WHEN A SECOND DRILL AND LONG ATTACHMENT, AND THE SAME BURR WERE ADDED INTO THE FIRST HANDPIECE, THEY HAD NOT BEEN PUT TOGETHER PROPERLY, SO THEY FAILED CALIBRATION. UPON REMOVING THE SECOND DRILL FROM THE FIRST HANDPIECE, THE SECOND LONG ATTACHMENT GOT STUCK IN THE FIRST HANDPIECE AND COULDN'T BE REMOVED. THEREFORE, THE SURGEON WAS REPEATEDLY HIT WITH A MALLET, BREAKING THE FIRST HANDPIECE, AND POTENTIALLY DAMAGING THE SECOND LONG ATTACHMENT AND SECOND DRILL. THEY OPENED A SECOND HANDPIECE AND CONTINUED USING THE PREVIOUS DRILL 2 AND LONG ATTACHMENT 2, BUT THE NURSE FOUND IT DIFFICULT TO INSERT THE BURR INTO LONG ATTACHMENT (PREVIOUSLY DAMAGED WITH THE SURGEON'S HAMMERING), SO THE SURGEON HAMMERED IT IN. THE HANDPIECE THEN PASSED CALIBRATION AND THE SURGEON STARTED TO USE IT TO REMOVE BONE, BUT AT SOME POINT, THE BURR DETACHED FROM THE SECOND DRILL AND WOULDN'T STAY INSIDE THE DRILL EVEN WHEN ASSEMBLED CORRECTLY (PREVIOUSLY DAMAGED WITH THE SURGEON'S HAMMERING). FINALLY, THE SURGERY WAS COMPLETED SATISFACTORILY USING A THIRD HANDPIECE, DRILL, AND LONG ATTACHMENT WITH A SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED. AFTER SURGERY, DURING TESTING, IT WAS FOUND THAT THE BURR WOULDN'T GO INTO THE FIRST LONG ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873145 NAVIO LONG ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSR110006 00885556628607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PFSR101209, ANSPACH HAND PIECE - SNK09311277002| PFSR101209, ANSPACH HAND PIECE - SNK09311348901| PFSR110137, NAVIO HANDPIECE - (B)(6) | ROB00049, NAVIO SURGICAL SYSTEM UK, (B)(6)