BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO TISSUE PROTECTOR

    MDR report key: 9743005 · Received February 23, 2020

    Report

    Report Number
    3010266064-2018-00013
    Event Type
    Injury
    Date Received
    February 23, 2020
    Date of Event
    September 4, 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
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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. 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

    VISUAL INSPECTION OF THE BROKEN BONE SCREW FOUND THAT THE TAPERED PORTION OF THE BONE SCREW WAS TWISTED. THE BONE SCREW IS STUCK IN THE TISSUE PROTECTOR WITH SIGNS OF BENDING AND TISSUE BEING PULLED INTO THE TISSUE PROTECTOR. IT WAS REPORTED THAT THE SCREW BROKE WHILE THE SURGEON WAS TRYING TO REMOVE IT. THEREFORE, THE DAMAGE IS DUE TO THE BONE SCREW BEING HELD RIGIDLY IN PLACE WITHIN THE TISSUE PROTECTOR WHILE BEING TIGHTENED OR LOOSENED. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BONE PIN BECAME LODGED IN THE TISSUE PROTECTOR DURING THE INSERTION OF THE PIN INTO THE PATIENT'S TIBIA. WHILE HOLDING THE TISSUE PROTECTOR, THE SURGEON ATTEMPTED TO REMOVE THE PIN WITH A POWERED HANDPIECE. THE PIN BROKE AT THE JUNCTION OF THE TISSUE PROTECTOR AND THE PIN INSERTER. THE SURGEON THEN REMOVED THE SECOND PIN WHICH HAD BEEN PREVIOUSLY INSERTED AND WAS ABLE TO REMOVE THE BROKEN PIN THAT WAS LODGED IN THE TISSUE PROTECTOR BY SPINNING THE TISSUE PROTECTOR ALLOWING THE PIN TO UNTHREAD FROM THE BONE. THE SURGEON COMPLETED THE PROCEDURE BY PLACING THE REMAINING PINS FREEHAND. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206177 NAVIO TISSUE PROTECTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention BONE PIN (PN 101111)