BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO SOFT TISSUE PROTECTOR

    MDR report key: 9706213 · Received February 13, 2020

    Report

    Report Number
    3010266064-2020-00034
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    May 9, 2019
    Report Date
    September 29, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628713
    Removal / Correction Number
    Z-1634-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A1.

    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 · 1

    RESULTS OF INVESTIGATION: THE RETURNED TISSUE PROTECTOR DID NOT APPEAR TO BE SIGNIFICANTLY BENT. FOUR BONE PINS WERE DROPPED DOWN THE TWO GUIDES AND EACH ONE DROPPED ALL THE WAY THROUGH WITHOUT ANY ISSUE. THE RETURNED TISSUE PROTECTOR IS NOT BENT, NO PROBLEM FOUND. THE ISSUE WAS REPORTED TO BE NOTICED BY THE SCRUB TECHNICIAN AND RECON REPRESENTATIVE. IT IS POSSIBLE THAT THERE WAS DEBRIS IN THE TISSUE PROTECTOR GUIDE THAT WAS CAUSING THE BONE PIN TO GO THROUGH IT AT AN ANGLE, BUT SINCE WE WERE NOT PRESENT AT THE TIME OF THE CASE WE CANNOT CONFIRM OR DENY THIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SCRUB TECH AND RECON REP THAT THE TISSUE PROTECTOR WAS SLIGHTLY BENT ON ONE SIDE. THE PIN SLID NICELY THROUGH ONE GUIDE, BUT HAD A DIFFICULT TIME SLIDING THROUGH THE OTHER. THERE WAS NO PATIENT INVOLVEMENT. DEVICE WAS NOT DURING USE WHEN EVENT OCCURRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170763 NAVIO SOFT TISSUE PROTECTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSR101092 00885556628713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown