BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996835 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00195
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    March 30, 2015
    Report Date
    August 7, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO HANDPIECE, USED IN TREATMENT, WAS RETURNED FOR FURTHER EVALUATION AND THE INITIAL VISUAL CONFIRMED THE REPORTED EVENT. THE SCREENSHOTS FROM THE CASE ARE CONSISTENT WITH A DRILL THAT WAS UNSNAPPED FROM THE HANDPIECE. THE AFFECTED HANDPIECE IS ON A LIST OF HANDPIECES THAT HAVE A KNOWN POTENTIALLY BAD SNAP LOCK. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE DUE TO SUPPLIER / RAW MATERIAL FAULT. A DEVICE HISTORY RECORD REVIEW FOUND 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 NAVIOPFS SYSTEM FOR UNICONDYLAR KNEE REPLACEMENT (UKR) USER'S MANUAL CONTAINS NO INFORMATION REGARDING THE BROKEN SNAP LOCK WHICH LED TO THE DRILL UNSNAPPING FROM THE HANDPIECE. THIS FAILURE IS ALSO CAPTURED IN THE NAVIO RISK PROFILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED A HOMING FAILURE. NECESSARY TROUBLESHOOTING WAS PERFORMED, AND THE HANDPIECE NEEDED TO BE REPLACED TO CONTINUE WITH THE CASE. NO SURGICAL DELAY OR PATIENT INJURY WAS REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DRILL GUIDE SUPPORT ON THE HANDPIECE WAS BENT, WHICH MAKES IT A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462141 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR