BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURAGEN NERVE GUIDE 3MM ID X 3CM LENGTH

    MDR report key: 11815787 · Received May 12, 2021

    Report

    Report Number
    1121308-2021-00020
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 3, 2021
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    PMA / PMN Number
    K011168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEURAGEN NERVE GUIDE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED TO REPORTED LOT: 3441665 AND NO ANOMALY WAS FOUND THAT COULD BE RELATED TO THE USE OF AN EXPIRED UNIT. THE LOT EXPIRATION DATE IS THE SAME AS THE ONE REPORTED BY THE CUSTOMER (31 JAN 2021). ALL LABELS (INCLUDING TYVEK LIDS) SHOW THE CORRECT EXPIRATION DATE. FAILURE ANALYSIS - A VISUAL INSPECTION OF THE RETAIN SAMPLES WAS REQUESTED. TEN (10) UNITS WERE VISUALLY INSPECTED. PACKAGING WAS IN GOOD CONDITION; TRAY SEALS WERE ACCEPTABLE, AND PRODUCT/SPONGE APPEARANCE WAS NORMAL. NO DEFECT WAS OBSERVED IN ANY OF THE UNITS INSPECTED. EXPIRATION DATE PRINTING WAS CLEAR AND VISIBLE IN SEVERAL PLACES (BOX AND TRAY). THE EXPIRATION DATE WAS 01/31/2021, AS REPORTED. THE CONDITION IS CONSIDERED CONFIRMED SINCE THE PRODUCT WAS EXPIRED AT THE TIME OF USE. THEREFORE, THE ROOT CAUSE FOR THIS COMPLAINT IS THE RESULT OF TWO (2) EVENTS: 1) THE ACCOUNT MANAGER DID NOT REMOVE THE EXPIRED STOCK. 2) HOSPITAL PERSONNEL DID NOT NOTICE THAT THE PRODUCT WAS EXPIRED PRIOR TO USE. ADDITIONAL INFORMATION RECEIVED: IMPLANTATION DATE: ON (B)(6) 2021 EXPIRATION DATE: ON (B)(6) 2021. AFTER THE PROCEDURE WAS COMPLETED, MEDICAL STAFF REALIZED THAT THE IMPLANTED PRODUCT WAS EXPIRED. THE HOSPITAL HAS NOT REPORTED ANY PATIENT SUBSEQUENT ISSUES AND THERE IS NO PLAN TO EXPLANT THE PRODUCT. ACCORDING TO FACILITY: A LOCAL INVESTIGATION WAS COMPLETED, AND IT WAS DETERMINED THAT THE INVENTORY WAS ON CONSIGNMENT WITH THE CUSTOMER AND HAD EXPIRED WHILE ON THE CUSTOMER SHELF AND WAS NOT REMOVED FROM STOCK AND REPLACED WITH NEW STOCK). IN ADDITION, THE HOSPITAL DID NOT DETECT THAT THE ITEM HAD EXPIRED AND IT WAS ONLY NOTICED AFTER THE PROCEDURE HAD BEEN COMPLETED AND PRODUCT HAD BEEN IMPLANTED. A CAPA/IMPROVEMENT REQUEST HAS BEEN RAISED TO REVIEW LOCAL CONSIGNMENT PROCESS AND METHODS FOR ENSURING CONSIGNMENT COUNTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN EXPIRED NEURAGEN NERVE GUIDE WAS IMPLANTED INTO PATIENT. NO DELAY IN SURGERY AND NO PATIENT INJURY REPORTED. PROCEDURE: NERVE EXPLORATION / NEUROMA EXCISION + REPAIR LEFT LITTLE FINGER + NERVE WRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707527 NEURAGEN NERVE GUIDE 3MM ID X 3CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORPORATION 3441665

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR