BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMATOME HOSE

    MDR report key: 9309396 · Received November 12, 2019

    Report

    Report Number
    0001526350-2019-00998
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 11, 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
    IL, 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)(4), 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. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REPROCESSING THAT THE CORD (HOSE) WAS DAMAGED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104441 DERMATOME HOSE DERMATOME GFD ZIMMER SURGICAL, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1