BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO

    MDR report key: 6622656 · Received June 8, 2017

    Report

    Report Number
    3010266064-2017-00011
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    June 1, 2017
    Report Date
    October 5, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW
    Product Code
    OLO
    PMA / PMN Number
    K160537
    Removal / Correction Number
    Z-1634-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    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. WHILE THE COMPLAINT DOES SUGGEST THAT THE USER MAY HAVE DEVIATED FROM THESE INSTRUCTIONS FOR NOT INSERTING THE PINS IN THE CORRECT SEQUENCE, THE FUNCTIONAL EVALUATION CONTINUES TO SUGGEST THAT THE CAUSE OF THE COMPLAINT CONCERNS THE DESIGN OF THE TISSUE PROTECTOR. SPECIFICALLY, 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).

    Description of Event or Problem · 1

    WHILE PLACING THE TIBIAL BONE PINS THE SURGEON FIRST PLACED ONE BONE PIN WITHOUT THE SOFT TISSUE PROTECTOR, THEN USED THE SOFT TISSUE PROTECTOR OVER THE FIRST PIN, AND DRILLED IN THE SECOND PIN. THE FIRST PIN WAS COMPLETELY INSIDE OF THE SOFT TISSUE PROTECTOR AND NOT EXPOSED AT ALL. WHEN THE SURGEON TRIED TO REMOVE THE SOFT TISSUE PROTECTOR, IT WAS STUCK. HE TRIED TO USE A MALLET AND PROVIDE AN UPWARD FORCE ON THE SOFT TISSUE PROTECTOR BUT IT WAS COMPLETELY STUCK. THE DRILL WAS USED TO TRY TO BACK OUT THE EXPOSED BONE PIN HOWEVER, IT WOULD NOT BACK OUT. THE TEE HANDLE WRENCH WAS THEN USED TO ATTEMPT TO MANUALLY BACK OUT THE PIN, BUT IT SNAPPED PART OF THE EXPOSED PIN OFF. AFTER A FEW MORE MINUTES AND ATTEMPTS TO USE A MALLET TO FORCEFULLY REMOVE SOFT TISSUE PROTECTOR, THE DRILL WAS USED AGAIN ON THE PORTION OF THE EXPOSED BONE PIN. THE TORQUE OF THE DRILL MAY HAVE CAUSED THE PIN TO BREAK BECAUSE THE PIN SNAPPED IN THE BOTTOM PORTION OF THE PIN THREADING. THERE WAS ABOUT AN INCH AND A HALF OF BONE PIN STILL DRILLED INTO THE PATIENTS BONE. AT THIS POINT, A CORING TOOL AND PLIER HAD TO BE USED TO REMOVE THE REMAINING PORTION OF THE PIN THAT WAS LODGED IN THE PATIENTS BONE. NEW PINS WERE THEN PLACED AT NEW PIN SITES USING THE TRACKER CLAMP AS A GUIDE RATHER THAN A SOFT TISSUE PROTECTOR. THE NAVIO WAS THEN USED TO COMPLETE THE CASE. UPON REMOVING THE BONE PINS AT THE END OF THE CASE, WE FOUND THAT ONE OF THE TIBIAL BONE PINS PLACED AT THESE NEW PIN SITES BENT. THE SITE OF THE BROKEN BONE PIN THAT HAD A CORING TOOL USED ON IT HAD TO BE FILLED WITH BONE PUTTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407273 NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED OLO BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NPFS02000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention