BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 10432027 · Received August 20, 2020

    Report

    Report Number
    3010266064-2020-01723
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 27, 2020
    Report Date
    June 30, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628904
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO HANDPIECE P/N 110004, S/N (B)(6) USED FOR TREATMENT WAS RETURNED FOR EVALUATION. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. THE "COULD NOT COMMUNICATE WITH HANDPIECE ERROR" APPEARED AT THE START OF THE HANDPIECE TEST. 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. THE MOST LIKELY CAUSE OF THIS EVENT IS MISHANDLING DURING SHIPPING, STORAGE, USE OR REUSE OF THE DEVICE, WEAR AND TEAR OVER TIME. THE USE OF CARE AND CAUTION SHOULD BE EXERCISED DURING THE SURGICAL SITE SETUP AND TEAR DOWN TO PROTECT THE DRILL AND HANDPIECE CABLE FROM SHARP OBJECTS OR FROM SITUATIONS THAT PIN THE CABLE BETWEEN TWO OBJECTS. DO NOT USE EXCESSIVE FORCE ON THE DRILL AND HANDPIECE STRAIN RELIEFS DURING THE DECONTAMINATION PROCESS TO MINIMIZE SEPARATING THE CABLE FROM THE STRAIN RELIEF. REFER TO THE NAVIO SURGICAL SYSTEM USER'S MANUAL AND THE NAVIO SURGICAL SYSTEM INSTRUMENT KIT CLEANING AND STERILIZATION GUIDE FOR PROPER HANDLING. BASED ON THE INVESTIGATION, NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NAVIO UKR PROCEDURE, AFTER IMPLANT PLANNING WHEN THE SURGEON WANTED TO BURR THE FEMUR, THE MESSAGE HANDPIECE EXPOSURE CONTROL MOTOR FAILURE APPEARED. THEY OPENED ANOTHER NAVIO SET INSTRUMENT TO SWAP THE HANDPIECE TO CONTINUE THE PROCEDURE WITHOUT ISSUES. THERE WAS A DELAY OF 10 MINUTES. AFTER THE SURGERY, BOTH HANDPIECE AND ANSPACH WERE TESTED AND WERE FINE. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895491 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSDV0016 00885556628904

    Patients

    Seq Age Sex Outcome Treatment
    1 CN: NPFS02020, SN: (B)(4)