BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE MIXING BOWL AND SPATULA

    MDR report key: 10442161 · Received August 24, 2020

    Report

    Report Number
    0001822565-2020-02975
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    February 14, 2020
    Report Date
    August 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    GAF
    UDI-DI
    00889024376564
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-02973, 0001822565-2020-02974, 0001822565-2020-02975. VISUAL EVALUATION OF THE RETURNED PRODUCTS CONFIRMED THE PRESENCE OF LOOSE BLUE PARTICLES INSIDE THE SEALED POUCH FOR THREE OF THE TWENTY UNITS. THE THREE UNITS CONTAINS EACH ONE LOOSE BLUE PARTICLE. ALL THE BLUE PARTICLES HAVE A SIZE GREATER THAN 0.60 SQ.MM AS MEASURED WITH TAPPI CHART, WHICH IS NOT ACCEPTABLE. THE COMPLAINT IS CONFIRMED COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE THREE UNITS WHEN THEY LEFT ZIMMER BIOMET CONTROL IS CONSIDERED NON-CONFORMING. THE BLUE PARTICLES LIKELY CAME FROM THE EXCESS FLASH GENERATED DURING THE MOLDING PROCESS OF THE MIXING BOWL AND/OR DURING THE TRIMMING OF THIS EXCESS FLASH. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING ISSUE. THE FOLLOWING ACTIONS WERE PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE, A CHANGE TO MANUFACTURING HAS BEEN IMPLEMENTED TO REDUCE FLASH AND REDUCE TRIMMING. THE REPORTED PRODUCT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS MANUFACTURING CHANGE. 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 THERE WAS DEBRIS IN THE STERILE PACKAGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907390 DISPOSABLE MIXING BOWL AND SPATULA SURGICAL INSTRUMENT GAF ZIMMER BIOMET, INC. N/A 64435604 00889024376564

    Patients

    Seq Age Sex Outcome Treatment
    1