BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO

    MDR report key: 7478491 · Received May 1, 2018

    Report

    Report Number
    3010266064-2018-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    April 2, 2018
    Report Date
    October 4, 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
    TC
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 NOT RETURNED FOR A PRIOR INVESTIGATION AT THE TIME OF THE OCCURRENCE. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. A PHOTO 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 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. 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 NAVIO TISSUE PROTECTOR WAS BENT, SO THE CORTICAL PINS COULD NOT BE INTRODUCED (BONE PINS STAYED STUCK INSIDE THE GUIDE). THE MALFUNCTION WAS ABLE TO BE RESOLVED BY BACKING OUT THE SCREW WHILE STILL ATTACHED TO THE TISSUE PROTECTOR. AFTER REMOVAL OF THE SCREW, THE CASE WAS COMPLETED UTILIZING BACKUP EQUIPMENT (SURGICAL DELAY < 5 MINUTES). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318508 NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO OLO BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention