BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL-SIZE LID W/RETENTION PLATE SILVER

    MDR report key: 5493706 · Received March 10, 2016

    Report

    Report Number
    2916714-2016-00155
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 2, 2016
    Report Date
    March 10, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    FRG
    PMA / PMN Number
    K053389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 ADDITIONAL 510(K) / PROCODE: K792558 / FLE MANUFACTURING SITE EVALUATION: ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). UPON OPENING OF STERILIZED CONTAINER FOR ORTHOPEDIC PROCEDURE, IT WAS NOTICED THAT THE FILTER HOLDER HAD FALLEN INTO THE CONTAINER; STERILITY COULD NOT BE ASSURED. ADDITIONAL INSTRUMENT SET HAD TO BE OBTAINED WHICH RESULTED IN DELAY OF APPROXIMATELY 30 MINUTES WITH PATIENT UNDER ANESTHESIA. ADDITIONAL COMPONENT INVOLVED: JK100 / FILTER RETENTION PLATE - MEDWATCH REPORT FILED ON THIS COMPONENT : 2916714-2016-00194.

    Additional Manufacturer Narrative · 1

    DURING SURGERY THE CONTAINER WAS OPENED AND THE CUSTOMER REALIZED THAT THE FILTER HOLDER HAS FALLEN INTO THE CONTAINER. SO STERILITY WAS NOT SURE. THE CONTAINER LID IS IN A USED CONDITION, SEVERAL SCRATCHES ARE VISIBLE. THE RETENTION PLATES ARE ALSO USED, BUT NO SEVERE DAMAGE CAN BE IDENTIFIED. THE PRODUCTS WERE ANALYZED VISUALLY AND SEVERAL FUNCTION TEST WERE CARRIED OUT. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RECREATED THE DESCRIBED ERROR, BUT THE RETENTION PLATES, SO WE CAN EXCLUDE A PRODUCTION OR MATERIAL CAUSED ERROR. MOST LIKELY THE RETENTION PLATE WAS NOT ASSEMBLED PROBABLY DURING THE MOUNTING. ACCORDING TO SOP SA-DE13-M-4-2-01-010 A CAPA IS NOT NECESSARY. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148390 FULL-SIZE LID W/RETENTION PLATE SILVER STERILIZATION CONTAINER LID FRG AESCULAP AG JK489

    Patients

    Seq Age Sex Outcome Treatment
    1 Other