BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 13653812 · Received March 2, 2022

    Report

    Report Number
    3010266064-2022-00157
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 11, 2022
    Report Date
    May 17, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628515
    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: CASE: (B)(4).

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE NAVIO HANDPIECE, PFSR110137, S/N(B)(6), USED FOR TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT (PHYSICAL RESISTANCE/STICKING) AND THE DEVICE COULD NOT BE ESTABLISHED DUE TO DAMAGED/BROKEN PARTS. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED FAILURE. A FUNCTIONAL EVALUATION COULD NOT BE COMPLETED DUE TO DAMAGED/BROKEN PARTS. THE SNAP LOCK IS IN PIECES. THE SECOND ISSUE (BREAK) WAS VISUALLY CONFIRMED. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, THE MOST LIKELY CAUSE OF THIS EVENT IS IMPROPER HANDLING OF THE HANDPIECE. IN THE EVENT THE DRILL/LONG ATTACHMENT IS STUCK IN THE HANDPIECE, DO NOT USE EXCESSIVE FORCE TO REMOVE THE DRILL/LONG ATTACHMENT. IT IS MOST LIKELY STUCK DUE TO LACK OF LUBRICATION THAT IS TO BE APPLIED TO THE SNAP LOCK PRIOR TO STERILIZATION. PLACE THE DRILL/LONG ATTACHMENT/HANDPIECE INTO THE STERILIZER. FOLLOWING COOLING, THE PARTS WILL SEPARATE. LUBRICATE THE SNAP LOCK PRIOR TO STERILIZATION TO MINIMIZE THIS EVENT. THE NAVIO SURGICAL SYSTEM USER'S MANUAL PROVIDES INSTRUCTIONS FOR PROPER SET UP OF THE DEVICE AND ACCESSORIES. CARE AND CAUTION SHOULD BE EXERCISED DURING THE SURGICAL SITE SETUP, SURGERY AND TEAR DOWN TO PROTECT THE DEVICE FROM AN UNFORESEEN FORCE, OR DAMAGE. REFER SERVICING ONLY TO TRAINED SMITH & NEPHEW SERVICE PERSONNEL. EQUIPMENT DAMAGE OR PERSONAL INJURY MAY RESULT IF THE SYSTEM IS NOT SERVICED PROPERLY. A REVIEW OF MANUFACTURING AND SERVICE 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. THE REVIEW DETERMINED THAT PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THIS COMPLAINT HOWEVER NO FURTHER ESCALATION ACTION IS REQUIRED. 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, THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION 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
    2292527 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSR110137 00885556628515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ANSPACH EMAX 2 PLUS HAND PIECE, SN(B)(6)| ANSPACH EMAX 2 PLUS HAND PIECE, SN(B)(6)| LONG ATTACHMENT,SN(B)(6)| LONG ATTACHMENT,SN(B)(6)| NAVIO SURGICAL SYSTEM UK,SN(B)(6)