BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MIXING BOWL AND SPATULA

    MDR report key: 18429301 · Received January 2, 2024

    Report

    Report Number
    0001822565-2024-00010
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 12, 2023
    Report Date
    March 22, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDZ
    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 · 0

    (B)(4). G2: FOREIGN: JAPAN 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND A HAIR-LIKE FIBER IN THE SEALED STERILE PACKAGING THAT IS NOT ACCEPTABLE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONSIDERED NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS PROVIDED. THIS COMPLAINT HAS BEEN CONFIRMED BY EVALUATION OF THE RETURNED PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INCOMING INSPECTION THAT A TEAM MEMBER FOUND A HAIR LIKE SUBSTANCE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451473 DISPOSABLE MIXING BOWL AND SPATULA HIPS, INSTRUMENTS JDZ ZIMMER BIOMET, INC. N/A 66330621 00889024376564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown