BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE PARANASAL - RIGHT - 30MM X 28MM

    MDR report key: 8383102 · Received March 1, 2019

    Report

    Report Number
    0008010177-2019-00005
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    February 18, 2019
    Report Date
    September 9, 2019
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    UDI-DI
    07613252086031
    PMA / PMN Number
    FWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED BASED ON THE VISUAL INSPECTION OF THE RETURNED PRODUCT. THE TAMPER-PROOF SEAL WAS BROKEN AND EXCEPT FROM THE IFU THERE WAS NO ADDITIONAL CONTENT ANYMORE WITHIN THE CLAMSHELL. THE DEVICE WAS MANUFACTURED BY STRYKER ORTHOBIOLOGICS IN MALVERN (USA). THEREFORE, THE AVAILABLE COMPLAINT INFORMATION WAS FORWARDED TO THE MANUFACTURING SITE TO REVIEW THE RELATED QUALITY AND MANUFACTURING DOCUMENTS. ALL RELEVANT DOCUMENTS HAVE BEEN REVIEWED BY THE SUPPLIER. THE DEVICE HISTORY RECORD FOR THE ¿LARGE PARANASAL - RIGHT - 30MM X 28MM¿, CATALOG # 9526, LOT CODE # A1308042, INDICATES (B)(4) UNITS WERE MANUFACTURED TO SPECIFICATION AND ACCEPTED INTO FINAL STOCK ON 2013-OCT-08 WITH NO REPORTED DISCREPANCIES. ADDITIONALLY, A VISUAL INSPECTION OF A RETAINED SAMPLE FROM THE SAME LOT AS THE COMPLAINED PRODUCT WAS PERFORMED. THE TAMPER-PROOF SEAL OF THE CLAMSHELL IS NOT TORN AND THE IMPLANT IS STILL CONTAINED WITHIN THE PACKAGING SYSTEM. TO GAIN MORE INFORMATION ABOUT THE COMPLAINED EVENT THE SALES REP WAS CONTACTED. IT WAS STATED THAT THE SALES REP DID NOT TAKE THE IMPLANT DIRECTLY INTO THE OPERATING ROOM, AND INSTEAD THE PRODUCT WAS DELIVERED FROM THE NEW ZEALAND WAREHOUSE TO THE HOSPITAL VIA COURIER. IT WAS ADDITIONALLY DISCOVERED THAT THE IMPLANT HAD IN FACT ALREADY BEEN TRANSFERRED THROUGH SEVERAL AUSTRALIAN STATE WAREHOUSES AND AUSTRALIAN HOSPITALS PRIOR TO COMING TO NEW ZEALAND. BASED ON THAT IT SEEMS WITHIN REASON TO BELIEVE THAT THE IMPLANT WAS USED OR REMOVED DURING THIS TIME. SUMMARIZING ALL OBTAINED INFORMATION, THE MAIN ROOT CAUSE FOR THE REPORTED EVENT IS MOST LIKELY RELATED TO A DISTRIBUTION ISSUE. FURTHER, IT NEEDS TO BE EMPHASIZED THAT DESPITE THE LABELING INFORMATION ¿DO NOT USE IF PACKAGE IS DAMAGED¿, THE PRODUCT WAS FORWARDED INTO THE OPERATING ROOM AND OPENED WITHIN THE STERILE AREA. THIS IS CONSIDERED AS AN OFF-LABEL USE. BASED ON THE INVESTIGATION INCLUDING A STATISTICAL ANALYSIS, THE DHR REVIEW OF THE RELATED MANUFACTURING AND QUALITY DOCUMENTS, THE VISUAL INSPECTION OF THE RETAINED SAMPLE, AS WELL AS, BASED ON THE FEEDBACK OF THE SALES REP, THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL, OR MANUFACTURING RELATED ISSUE. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A CIRCULATING NURSE THAT DURING A MEDICAL PROCEDURE TO PLACE AN IMPLANT WHEN OPENING THE IMPLANT CONTAINER IT WAS FOUND THE SEAL HAD BROKEN AND THE CONTAINER WAS EMPTY. A REVISION SURGERY HAD TO BE PLANNED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE TO STRYKER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CIRCULATING NURSE THAT DURING A MEDICAL PROCEDURE TO PLACE AN IMPLANT WHEN OPENING THE IMPLANT CONTAINER IT WAS FOUND THE SEAL HAD BROKEN AND THE CONTAINER WAS EMPTY. A REVISION SURGERY HAD TO BE PLANNED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177167 LARGE PARANASAL - RIGHT - 30MM X 28MM IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN A13080420023000 07613252086031

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR