BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER GPS DUAL TIP MALABLE 20GAX7IN

    MDR report key: 6897943 · Received September 27, 2017

    Report

    Report Number
    0001825034-2017-07341
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KYZ
    PMA / PMN Number
    PK940371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: KYZ COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THAT THE PACKAGING WAS NOT SEALED ON THE BOTTOM SIDE OF THE POUCH AS REPORTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY FROM THE SUPPLIER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PROCESSING (B)(4), THE PART WAS CHECKED AND FOUND THAT THE BOTTOM OF THE POUCH WAS NOT SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678865 ZIMMER GPS DUAL TIP MALABLE 20GAX7IN SYRINGE, IRRIGATING KYZ ZIMMER BIOMET, INC. N/A 166239

    Patients

    Seq Age Sex Outcome Treatment
    1