BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL-SIZE LID W/RETENTION PLATE SILVER

    MDR report key: 6029699 · Received October 14, 2016

    Report

    Report Number
    2916714-2016-00848
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 30, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    FRG
    PMA / PMN Number
    K053389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT WHILE PREPARING FOR A TOTAL KNEE ARTHROPLASTY SURGERY, WHEN OPENING THE COVER TO USE INSTRUMENTS THE FILTER WITH THE HOLDER DROPPED INSIDE THE CONTAINER. THERE WAS A TWO-HOUR DELAY IN SURGERY IN ORDER TO COMPLETE A STERILIZATION ON THE INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A (B)(6). WE MADE A VISUAL INSPECTION OF THE INLAY SHEET JK100240. HERE WE FOUND A BENT NOSE. ADDITIONALLY WE MADE A VISUAL INSPECTION OF THE CONTAINERS LOWER COVER SILVER JK489200. HERE WE FOUND BENT EDGES, A VISIBLY DAMAGED EDGE AND OTHER VISIBLE DAMAGES. FURTHERMORE WE FOUND A BENT AND LOOSE LOCKING BOLT JK221224. ON THE OPPOSITE SIDE WE FOUND CRACKS. ADDITIONALLY, WE FOUND A DEFORMED COVER. WE MADE A VISUAL INSPECTION OF THE HOUSING MOUNTED JK100950. HERE WE FOUND VISIBLY DAMAGED PINS AND A VISIBLY DAMAGED SURFACE. ADDITIONALLY WHEN ASSEMBLING THE FILTER RETENTION PLATE JK100 AT THE UNDAMAGED LOCKING BOLT JK221224. HERE WE FOUND A GAP THAT IS TOO WIDE. THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. WE ASSUME THAT THE DAMAGES AT THE INLAY SHEET JK100240, CONTAINER LOWER COVER JK489200, LOCKING BOLT JK221224 AND HOUSING MOUNTED JK100950 WERE CAUSED BY IMPROPER HANDLING. THERE IS THE POSSIBILITY THAT THE DEFORMED COVER WAS CAUSED BY VACUUM DAMAGE DUE TO INADEQUATE PRESSURE EQUALIZATION. THE GAP BETWEEN THE FILTER RETENTION PLATE JK100 AND THE CONTAINER LOWER COVER WAS PROBABLY CONTRIBUTED TO BY THE DEFORMED COVER. FURTHERMORE, DUE TO THE QUALITY STANDARD, A PRODUCTION ERROR OR MATERIAL DEFECT CAN BE EXCLUDED. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682358 FULL-SIZE LID W/RETENTION PLATE SILVER STERILE TECHNOLOGY FRG AESCULAP AG JK489

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other