BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO SURGICAL SYSTEM

    MDR report key: 6500337 · Received April 18, 2017

    Report

    Report Number
    3010266064-2017-00004
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    August 16, 2016
    Report Date
    October 5, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES INC
    Product Code
    OLO
    PMA / PMN Number
    K160537
    Removal / Correction Number
    Z-1634-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B1 WAS UPDATED TO REPORT TYPE ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    THE NAVIO SOFT TISSUE PROTECTOR, (PN 101092), USED IN TREATMENT WAS NOT RETURNED FOR A PRIOR INVESTIGATION. 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 NOT RETURNED. 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

    INVESTIGATION SUMMARY: THE CAUSE OF THE MALFUNCTION IS DUE TO A SMALL AMOUNT OF TISSUE BEING PULLED INTO THE TISSUE PROTECTOR CANNULA BY THE BONE SCREW AND CAUSING IT TO BIND WHEN THE PROTECTOR IS NOT PLACED FLUSH WITH THE BONE SURFACE. FROM TEST REPORT (B)(4) "BINDING OF THE BONE SCREW TO THE TISSUE PROTECTOR IS PRIMARILY DUE TO TISSUE BEING WRAPPED AROUND THE THREADS. HOWEVER, INITIAL PIN MISALIGNMENT, BENDING OF THE SCREWS, AND MISUSE OF THE TISSUE PROTECTOR ARE ALSO CLEARLY CONTRIBUTING FACTORS."

    Description of Event or Problem · 1

    A BONE SCREW BEING USED TO HOLD THE TRACKER MOUNT HAD BECOME BOUND IN THE TISSUE PROTECTOR DURING PLACEMENT OF THE BONE SCREW ON THE TIBIA. THE SURGEON REMOVED THE FIRST SCREW AND USED CUTTERS TO CUT THE EMPTY CANNULA OFF. THEY THEN USED THE TISSUE PROTECTOR TO UNSCREW THE SECOND BONE SCREW, RELEASING THE DEVICE WITH NO PARTS LEFT BEHIND IN THE PATIENT. THIS RESULTED IN A DELAY IN THE PROCEDURE, BUT NO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE, HENCE NO SERIOUS INJURY. THE SURGEON COMPLETED THE CASE WITH MANUAL INSTRUMENTATION PER INSTRUCTIONS IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281946 NAVIO SURGICAL SYSTEM NAVIO SURGICAL SYSTEM OLO BLUE BELT TECHNOLOGIES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| O