BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO

    MDR report key: 7146292 · Received December 26, 2017

    Report

    Report Number
    3010266064-2017-00021
    Event Type
    Injury
    Date Received
    December 26, 2017
    Date of Event
    November 27, 2017
    Report Date
    September 28, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. WHILE THE COMPLAINT DOES SUGGEST THAT THE USER MAY HAVE DEVIATED FROM THESE INSTRUCTIONS FOR NOT INSERTING THE PINS IN THE CORRECT LOCATION, 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

    IT WAS REPORTED THAT THE MOST DISTAL TIBIAL PIN WAS PLACED TOO HIGH UP ON THE TIBIAL CREST TO BE RIGIDLY FIXED. AFTER THE PIN WAS PLACED THROUGH THE TISSUE PROTECTOR WHEN ATTEMPTING TO REMOVE THE TISSUE PROTECTOR FROM THE PIN, THE PROTECTOR JAMMED ON THE PIN. THE PIN WAS TAPPED LIGHTLY WITH A MALLET BUT WOULD NOT COME LOOSE. SURGEON ATTEMPTED TO REMOVE THE PIN THROUGH THE TISSUE PROTECTOR USING A WIRE DRIVER TO GRASP THE PIN, BUT IT ONLY TWISTED THE HEAD OF THE PIN. THE PIN WAS KNOCKED OUT OF THE TIBIA WITH A MALLET FORCING THE THREADS THROUGH THE BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOST DISTAL TIBIAL PIN WAS PLACED TOO HIGH UP ON THE TIBIAL CREST TO BE RIGIDLY FIXED. AFTER THE PIN WAS PLACED THROUGH THE TISSUE PROTECTOR WHEN ATTEMPTING TO REMOVE THE TISSUE PROTECTOR FROM THE PIN, THE PROTECTOR JAMMED ON THE PIN. THE PIN WAS TAPPED LIGHTLY WITH A MALLET BUT WOULD NOT COME LOOSE. SURGEON ATTEMPTED TO REMOVE THE PIN THROUGH THE TISSUE PROTECTOR USING A WIRE DRIVER TO GRASP THE PIN, BUT IT ONLY TWISTED THE HEAD OF THE PIN. THE PIN WAS KNOCKED OUT OF THE TIBIA WITH A MALLET FORCING THE THREADS THROUGH THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924864 NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO OLO BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NPFS02000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention