BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMATOME HOSE

    MDR report key: 8800195 · Received July 17, 2019

    Report

    Report Number
    0001526350-2019-00560
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 12, 2019
    Report Date
    August 15, 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
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) FOR THE DERMATOME HOSE, PART NUMBER 00880100200 AND SERIAL NUMBER (B)(6), REVIEW BY LINVATEC CORP DBA CONMED 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. NOTE: COMPLAINT HISTORY SEARCH WAS PERFORMED USING ALL DERMATOME ITEM NUMBERS AS ALL COULD POTENTIALLY HAVE THE SAME FAILURE. NO FURTHER ACTION IS REQUIRED AS 2 OR LESS COMPLAINTS WERE IDENTIFIED OF THE SAME ITEM AND LOT NUMBERS. ON (B)(6) 2019, IT WAS REPORTED FROM (B)(6) THAT A DERMATOME HOSE WAS BLOWING OUT WHEN IN USE. ON 01 AUG 2019, A RETURNED PRODUCT INVESTIGATION WAS PERFORMED ON THE DERMATOME HOSE. THE PHYSICAL EVALUATION REVEALED THAT THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED AND THERE WERE NO OTHER ISSUES FOUND WITH THE DEVICE. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED AND NO OTHER ISSUES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE EVENT RECORDED BY ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DERMATOME HOSE AIR SUPPLY WAS BLOWING AIR OUT WHEN IN USE. THERE WAS NO HARM AND NO DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592147 DERMATOME HOSE DERMATOME GFD ZIMMER SURGICAL, INC. 968470

    Patients

    Seq Age Sex Outcome Treatment
    1