BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO

    MDR report key: 9743037 · Received February 23, 2020

    Report

    Report Number
    3010266064-2018-00012
    Event Type
    Injury
    Date Received
    February 23, 2020
    Date of Event
    August 17, 2018
    Report Date
    October 4, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES,
    Product Code
    OLO
    PMA / PMN Number
    K160537
    Removal / Correction Number
    Z-1634-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO SOFT TISSUE PROTECTOR, (PN 101092), USED IN TREATMENT WAS RETURNED FOR A PRIOR INVESTIGATION AND DISCARDED. DHR REVIEW FOUND THAT NO CONDITIONS THAT COULD CONTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE SURGICAL TECHNIQUE GUIDE PROVIDES INSTRUCTIONS FOR USING THE TISSUE PROTECTOR. SPECIFICALLY, THE GUIDE PROVIDES INSTRUCTION ON HOW TO PREPARE THE BONE PIN INSERTION LOCATION ON THE PATIENT AND HOW TO INSERT THE TISSUE PROTECTOR WITHIN THAT LOCATION. THE COMPLAINT DOES NOT SUGGEST THAT THE USER DEVIATED FROM THESE INSTRUCTIONS. MOREOVER, AS PART OF THE FUNCTIONAL EVALUATION IN TR0979 THAT REPLICATED THE ISSUE, THE TEST OPERATOR FOLLOWED THE INSTRUCTIONS PROVIDED IN THE SURGICAL TECHNIQUE GUIDE AND EXPERIENCED THE BONE PIN GETTING STUCK IN THE TISSUE PROTECTOR. ACCORDINGLY, PRODUCT LABELING HAS BEEN RULED OUT AS A CAUSE OF THE COMPLAINT. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. WE COULD NOT CONFIRM IF THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. PHOTOS OF THE DEVICE WERE NOT PROVIDED FOR EVALUATION AND THE DEVICE WAS DISCARDED AFTER A PRIOR INVESTIGATION. HOWEVER, BASED ON PRIOR COMPLAINTS RECEIVED IT IS LIKELY THAT THE EVENT OCCURRED DUE TO THE REPORTED FAILURE. THE MALFUNCTION IS DUE TO A DESIGN ISSUE DUE TO THE INNER DIAMETER OF THE TISSUE PROTECTOR LUMEN DIAMETER RELATIVE TO THE MAJOR DIAMETER OF THE BONE PIN. BINDING OF THE BONE SCREW TO THE TISSUE PROTECTOR IS PRIMARILY DUE TO TISSUE BEING WRAPPED AROUND THE THREADS. HOWEVER, INITIAL PIN MISALIGNMENT AND BENDING OF THE PIN ARE ALSO CONTRIBUTING FACTORS. HHE-2020-12-PL AND CAPA 200017 WERE OPENED AS CORRECTIVE ACTIONS TO ADDRESS THIS ISSUE. AS A RESULT OF THE REMEDIAL INVESTIGATION, WE HAVE THOROUGHLY INVESTIGATED THE COMPLAINT PER THE CRITERIA AS REQUIRED BY 21 CFR 820.198(D).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DRILL USED IN THE CASE WAS NOT FULLY POWERED. THE BONE PIN WAS REMOVED FROM THE FIRST TISSUE PROTECTOR USING A FULLY POWERED DRILL AS EXPECTED AND TISSUE AND BONE DUST CAME OUT. THE SECOND TISSUE PROTECTOR WAS TAPPED LIGHTLY ON A TABLE AND THE BONE PIN CAME OUT WITH NO ISSUE WITH BONE DUST. THEREFORE, IF THE DRILL HAD BEEN FULLY POWERED, THIS ISSUE WOULD NOT HAVE OCCURRED. THE BONE SCREWS MAY HAVE INITIALLY GOTTEN STUCK FROM DEBRIS OR INSUFFICIENT CLEANING. REPORT 2 OF 2. REFERENCE 3010266064-2018-00011 FOR 1ST DEVICE REFERENCED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BONE PINS BECAME STUCK IN THE TISSUE PROTECTORS TWICE DUE TO BONE DUST BUILDING UP AND ADHERING TO THE PINS DURING USE. THE FIRST TIME, THE TISSUE PROTECTOR HAD TO BE CUT OUT OF THE PATIENT. THE SECOND TIME, THE PIN WAS JUST STUCK INSIDE THE TISSUE PROTECTOR. THE PROCEDURE WAS COMPLETED USING A T-WRENCH TO TIGHTEN THE SCREWS INTO THE BONE. HOWEVER, THE ISSUE RESULTED IN A SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206054 NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED OLO BLUE BELT TECHNOLOGIES,

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention