BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 5008623 · Received August 17, 2015

    Report

    Report Number
    1221934-2015-00914
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY SYNTHES MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY SYNTHES MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. IN TRANSIT.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING CLOSED SINCE AFTER MULTIPLE EMAIL ATTEMPTS TO RETRIEVE THE PRODUCT, THE PRODUCT STILL HASN'T BEEN RETURNED FOR EVALUATION. IF AND WHEN THE DEVICE IN QUESTION IS RECEIVED, THIS FILE WILL BE REOPENED AND ITS CONTENTS MADE TO REFLECT THE RESULTS OF THE EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AS RELATED TO THE REPORTED PROBLEM; AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED FIVE OTHER SIMILAR COMPLAINTS FROM THE SAME SURGEON, AND ONE OTHER SIMILAR COMPLAINT FROM ANOTHER SURGEON FOR THIS LOT OF 638 ((B)(4) PACKS) DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE, ALTHOUGH THROUGH AN EARLIER COMPLAINT INVESTIGATION IT HAS BEEN REPORTED THAT THE SURGEON FROM THIS COMPLAINT DOES NOT FOLLOW THE INSTRUCTIONS SET FORTH IN THE IFU. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    NEEDLE BREAKAGE AT THE 2ND PASSAGE. THE NEEDLE BROKE WHEN REMOVED, THE PIECE WAS RETRIEVED. NO PATIENT CONSEQUENCE. THE NEEDLE WAS USED WITH 214124.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541509 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC SUTURE PASSER NEEDLE LXH DEPUY MITEK NA 28635

    Patients

    Seq Age Sex Outcome Treatment
    1