BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9984408 · Received April 21, 2020

    Report

    Report Number
    3010266064-2020-00774
    Event Type
    Injury
    Date Received
    April 21, 2020
    Date of Event
    May 9, 2018
    Report Date
    August 19, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K180271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. H3, H6: THE NAVIO HANDPIECE, INTENDED FOR USE IN TREATMENT, WAS RETURN FOR EVALUATION. THE NAVIO HANDPIECE WAS MALFUNCTIONING PRIOR TO A PROCEDURE. HAND PIECE WITH UNKNOWN SERIAL NUMBER HAD A STRIPPED SCREW AND IT COULD NOT BE CLOSED. A DEVICE HISTORY RECORD REVIEW FOUND NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT AND THE DEVICE MET ALL SPECIFICATIONS DURING RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS AND THIS ISSUE WILL CONTINUE TO BE MONITORED. THE NAVIO SURGICAL SYSTEM FOR UNICONDYLAR KNEE REPLACEMENT AND PATELLOFEMORAL ARTHROPLASTY USER'S MANUAL (500054 REV. G) RELEASED AT THE TIME OF THE COMPLAINT PROVIDES INSTRUCTIONS ON LUBRICATION OF THE NAVIO HANDPIECE. THIS FAILURE IS CAPTURED IN THE NAVIO RISK PROFILE. ONLY THE NAVIO HANDPIECE WITH SERIAL NUMBER (B)(6) WAS RETURNED FOR FURTHER EVALUATION AND THE INITIAL VISUAL/FUNCTIONAL INVESTIGATION OF SERIAL NUMBER (B)(6) FOUND THAT THE LONG ATTACHMENT WAS STUCK IN THE SNAP LOCK AND COULD NOT BE RELEASED. THE SNAP LOCK OF THAT HANDPIECE WAS COMPLETELY BROKEN. IT IS LIKELY THAT THE DRILL WAS STUCK BECAUSE OF LACK OF LUBRICATION. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE DUE TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UKR SURGERY, THE LONG ATTACHMENT TIP IS SPLIT, AND THE BEARINGS ARE VERY STIFF AND PRODUCING METAL DEBRIS. 5MM & 6MM EXPOSURE GUARDS NEED REPLACING AS THE BURR HAS BEEN HITTING THE METAL AND CAUSING IT TO EXPAND. ALSO NEED TO REPLACE TWO HANDPIECES AS ONE HAS A STRIPPED SCREW SO IT CANT BE CLOSED AND ONE HAS THE LONG ATTACHMENT STUCK IN THE HOUSING AND WE CANT RELEASE IT. THE PROCEDURE WAS COMPLETED BY CHANGING TO A MANUAL INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443819 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention