BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO

    MDR report key: 9743010 · Received February 23, 2020

    Report

    Report Number
    3010266064-2018-00010
    Event Type
    Injury
    Date Received
    February 23, 2020
    Date of Event
    July 30, 2018
    Report Date
    September 29, 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. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. PHOTOS OF THE DEVICE FROM THE PRIOR INVESTIGATION SHOWED THAT THE BONE PIN WAS STUCK IN THE TISSUE PROTECTOR. 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 RELEASED AT THE TIME OF THE COMPLAINT PROVIDES INSTRUCTIONS FOR USING THE TISSUE PROTECTOR. SPECIFICALLY, THE GUIDE DOES PROVIDE INSTRUCTION ON HOW TO PREPARE THE BONE PIN INSERTION LOCATION ON THE PATIENT AND HOW TO INSERT THE TISSUE PROTECTOR WITHIN THAT LOCATION. THE FUNCTIONAL EVALUATION SUGGESTS THAT THE CAUSE OF THE COMPLAINT CONCERNS THE DESIGN OF THE TISSUE PROTECTOR. SPECIFICALLY, AS PART OF THE FUNCTIONAL EVALUATION 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. 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

    INVESTIGATION NARRATIVE: THE RETURNED PIN DRIVER WORKED AS EXPECTED. NO PROBLEM FOUND. VISUAL INSPECTION OF THE BROKEN BONE SCREW FOUND THAT THE TAPERED PORTION OF THE BONE SCREW WAS TWISTED. IT WAS REPORTED THAT THE SCREW BROKE WHILE THE SURGEON WAS TRYING TO REMOVE THE BONE SCREW. THEREFORE, THE DAMAGE IS DUE TO THE BONE SCREW BEING HELD RIGIDLY IN PLACE WITHIN THE TISSUE PROTECTOR WHILE BEING TIGHTENED OR LOOSENED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SURGICAL PROCEDURE, THE BONE PIN GOT STUCK IN THE TISSUE PROTECTOR WHICH RESULTED IN A SURGICAL DELAY. SURGEON TRIED BACKING THE PIN OUT AND THE CONNECTION TURNED INTO A SPIRAL AND STRIPPED THE PIN DRIVER. THE TISSUE PROTECTOR WAS USED AS A T-WRENCH TO SPIN THE BONE PIN OUT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206471 NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED OLO BLUE BELT TECHNOLOGIES,

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention