BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO TISSUE PROTECTOR

    MDR report key: 8646261 · Received May 28, 2019

    Report

    Report Number
    3010266064-2019-00003
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 11, 2019
    Report Date
    October 4, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW
    Product Code
    OLO
    PMA / PMN Number
    K180271
    Removal / Correction Number
    Z-1634-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B1, B2 AND H1 WERE UPDATED TO REPORT TYPE ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    THE NAVIO SOFT TISSUE PROTECTOR, (PN 101092), USED IN TREATMENT WAS RETURNED FOR A PRIOR INVESTIGATION AND WAS 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 · 0

    VISUAL INSPECTION CONFIRMED THE REPORTED PROBLEM. THE BONE SCREW IS STUCK IN THE TISSUE PROTECTOR WITH SIGNS OF BENDING AND TISSUE BEING PULLED INTO THE TISSUE PROTECTOR. THE HEAD OF THE BONE SCREW (THE CONNECTION END) HAD BEEN BENT PRIOR TO BREAKING. WHEN THE HEAD BENDS, THE MATERIAL REACHES IS YIELD POINT AND THEN IS SIGNIFICANTLY WEAKENED, ALLOWING IT TO BE BROKEN OFF BY THE TORQUE OF THE DRILL AND THE RESISTANCE OF THE BONE. BENDING OF THE SCREW HEAD IS MOST COMMONLY DONE BY ALLOWING THE WEIGHT OF THE DRILL TO FALL WHILE ATTACHED TO THE SCREW. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATION UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE CANNULATED SECTIONS ON THE TISSUE PROTECTOR SNAPPED AND A BONE PIN BECAME STUCK IN THE REMAINING SECTION. PRIOR TO THE INCIDENT DURING THE PROCEDURE, THE PIN DRIVER INADVERTENTLY FELL OUT OF THE CHUCK AND ONTO THE FLOOR SO THE MINI CONNECT PIN DRIVER WAS USED. THIS DID NOT OFFER ENOUGH SUPPORT FOR THE LONG PIN. WHILST USING THE DOUBLE BARREL TISSUE PROTECTOR FOR THE PINS IN THE TIBIA, THE TOP PIN BENT AND THUS BECAME STUCK IN THE PROTECTOR. THIS PREVENTED CORRECT PLACEMENT OF THE SECOND PIN SO THE PROCESS HAD TO BEGIN AGAIN, HOWEVER THE SURGEON WAS UNABLE TO SWIVEL THE BARREL (THE BOTTOM BARREL WAS OBSTRUCTED BY SKIN IN BOTH DIRECTIONS) AS THE ANATOMY PREVENTED IT. ULTIMATELY, THE SURGEON CHOSE TO USE A BURR TO CUT THROUGH THE BOTTOM BARREL TO ENABLE THE REMOVAL OF THE ENTIRE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439308 NAVIO TISSUE PROTECTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O