BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MIXING BOWL AND SPATULA

    MDR report key: 10239883 · Received July 7, 2020

    Report

    Report Number
    0001822565-2020-02396
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 18, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDZ
    UDI-DI
    00889024376684
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THAT 18 OUT-OF-20 CONTAIN FOREIGN DEBRIS. SIXTEEN OF THE 20 STERILE POUCHES CONTAIN A LOOSE BLUE PARTICLE. ONE STERILE POUCH CONTAINS 2 PARTICLES. ALL LOOSE PARTICLES EXCEED THE .60 SQ. MM SIZE ALLOWED BY ZPC 8.400 REV.52, AS MEASURED WITH THE TAPPI CHART 25-2007-187-00-EY. ONE STERILE POUCH HAS A HAIR-LIKE FIBER MEASURING APPROXIMATELY .400 IN LENGTH. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE LIKELY CONDITION OF THE PARTS WHEN THEY LEFT ZIMMER BIOMET CONTROL IS CONSIDERED NON-CONFORMING BASED ON THE EVALUATION OF THE RETURNED PRODUCTS. THE LOOSE 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. ALTHOUGH A DEFINITIVE SOURCE OF THE HAIR-LIKE FIBER CANNOT BE DETERMINED, IT WAS INTRODUCED DURING MANUFACTURING BECAUSE IT WAS LOCATED IN THE SEALED POUCH. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING ISSUE. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-02390, 0001822565-2020-02391, 0001822565-2020-02392, 0001822565-2020-02393, 0001822565-2020-02394, 0001822565-2020-02395, 0001822565-2020-02397, 0001822565-2020-02398, 0001822565-2020-02399, 0001822565-2020-02401, 0001822565-2020-02402, 0001822565-2020-02403, 0001822565-2020-02404, 0001822565-2020-02405, 0001822565-2020-02406, 0001822565-2020-02407.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702716 DISPOSABLE MIXING BOWL AND SPATULA PROSTHESIS, HIP JDZ ZIMMER BIOMET, INC. N/A 64655319 00889024376684

    Patients

    Seq Age Sex Outcome Treatment
    1