BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERM II HOSE SYNTHES

    MDR report key: 9152823 · Received October 3, 2019

    Report

    Report Number
    0001526350-2019-00844
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 20, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE DERM II HOSE SYNTHES, PART NUMBER 00885100203 AND SERIAL NUMBER (B)(6), REVIEW BY DE-SOUTTER MEDICAL LIMITED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 20 SEPT 2019, IT WAS REPORTED FROM ZIMMER BIOMET FRANCE SAS THAT A DERM II HOSE SYNTHES WAS LEAKING FROM THE END OF THE HOSE. ON 30 OCT 2019, A RETURNED PRODUCT INVESTIGATION WAS PERFORMED ON THE DERM II HOSE SYNTHES. THE PHYSICAL EVALUATION REVEALED THAT THE O-RING THAT SEALS THE AIRFLOW FROM THE HOSE WAS MIS-SEATED WHICH ALLOWED FOR AIR TO LEAK FROM THE HOSE. THE RESULTS OF THE RETURNED PRODUCT INVESTIGATION HAVE CONFIRMED THE REPORTED EVENT. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE DERM II HOSE SYNTHES HAD A MIS-SEATED O-RING CAUSING AN AIR LEAK, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT ACTUALLY CAUSED THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOREIGN SOURCE: (B)(6). EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRODUCT INSPECTION AT ZIMMER BIOMET FRANCE, THE EMPLOYEE DETECTED THAT AIR IS LEAKING FROM THE END OF THE HOSE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946771 DERM II HOSE SYNTHES DERMATOME GFD ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1