BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO SOFT TISSUE PROTECTOR

    MDR report key: 9742783 · Received February 22, 2020

    Report

    Report Number
    3010266064-2020-00051
    Event Type
    Injury
    Date Received
    February 22, 2020
    Date of Event
    January 8, 2018
    Report Date
    September 28, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628713
    Removal / Correction Number
    Z-1634-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO SOFT TISSUE PROTECTOR, (PN 101092), USED IN TREATMENT WAS RETURNED FOR A PRIOR INVESTIGATION AND DISCARDED. 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 DURING PLACEMENT OF THE TIBIAL ARRAY PINS, A PIN BECAME LODGED IN THE TISSUE PROTECTOR. THIS WAS REMOVED MANUALLY, HOWEVER IT WAS UNABLE TO DISLODGE THE PIN FROM THE TISSUE PROTECTOR. A SECOND TRAY WAS OPENED AND ANOTHER TISSUE PROTECTOR WAS GIVEN TO THE SURGEON. WHILE ATTEMPTING TO PLACE AN ARRAY PIN WITH THE SECOND TISSUE PROTECTOR, THE PIN ALSO BECAME LODGE IN THE PROTECTOR. THE PINS WERE PLACED MANUALLY AND THE CASE PROCEEDED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206029 NAVIO SOFT TISSUE PROTECTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSR101092 00885556628713

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention