BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO BBT FOOTPEDAL

    MDR report key: 9990045 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-01236
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    June 14, 2019
    Report Date
    August 31, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628485
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED DURING TREATMENT AND WAS RETURNED FOR EVALUATION. THERE WAS NO LOT NUMBER INDICATED IN THE ORIGINAL COMPLAINT. HOWEVER, ALL LOTS OF PN 120031 DISTRIBUTED TO THE FIELD FROM WHEN THE PART NUMBER WAS FIRST INSPECTED TO THE COMPLAINT OCCURRENCE DATE WERE REVIEWED AND DID NOT FIND ANY ISSUES THAT COULD POTENTIALLY LEAD TO PERFORMANCE ISSUES. THEREFORE, THE DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND A REPORT OF THE ISSUE WAS FOUND. THIS ISSUE WILL CONTINUE TO BE MONITORED. THE FAILURE MODE IS IDENTIFIED IN THE RISK FILE. THE SURGICAL TECHNIQUE GUIDE RELEASED AT THE TIME OF THE COMPLAINT (PN 500095 REV#CD) PROVIDES INSTRUCTIONS ON HOW TO RECOVER TO A FULLY MANUAL PROCEDURE IN THE CASE THE OF A NAVIO SURGICAL SYSTEM FAILURE AT ANY POINT DURING THE SURGICAL CASE. SINCE THE REPORTED EVENT WAS RELATED TO A COMPONENT FAILURE, THERE IS NO INDICATION IN THIS COMPLAINT THAT THE USER DID NOT FOLLOW THE IFU. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED EVENT HAS NOT BEEN ESTABLISHED. THE FUNCTIONAL EVALUATION OF THE FOOT PEDAL FOUND THAT IT DID NOT GET STUCK WHEN PRESSED HARDER THAN USUAL. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. HOWEVER, A FACTOR THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS THAT DEBRIS COULD HAVE GOTTEN CAUGHT IN THE BLUE FOOT PEDAL PREVENTING IT FROM MOVING BACK UP FROM THE ACTIVE POSITION AT THE TIME OF THE COMPLAINT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. PER COMPLAINT DETAILS, THE DEVICE MALFUNCTION OCCURRED DURING SURGERY BUT THE PROCEDURE WAS CHANGED TO MANUAL INSTRUMENTATION TO COMPLETE THE SURGERY. THERE WAS NO MAJOR DELAY AND THEREFORE, NO PATIENT INJURY/IMPACT TO THE PATIENT; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: D10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLUE BELT FOOT PEDAL REMAINS PERMANENTLY IN THE ACTIVE POSITION. SURGERY WAS COMPLETED WITH LEGION STANDARD INSTRUMENTATION. IT IS UNKNOWN IF THERE WAS A DELAY BUT NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453505 NAVIO BBT FOOTPEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSR120031 00885556628485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention