BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MIXING BOWL AND SPATULA

    MDR report key: 16396273 · Received February 17, 2023

    Report

    Report Number
    0001822565-2023-00425
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDZ
    UDI-DI
    00889024379718
    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). REPORT SOURCE: JAPAN. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND ONE POUCH CONTAINS FOREIGN DEBRIS THAT EXCEEDS .60 SQ. MM., WHICH IS NOT ACCEPTABLE PER REVIEW OF ZPC 8.400. THIS COMPLAINT HAS BEEN CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS PROVIDE. 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 AT ZB WAREHOUSE IN JAPAN, A TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGING. NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135173 DISPOSABLE MIXING BOWL AND SPATULA HIPS, INSTRUMENTS JDZ ZIMMER BIOMET, INC. N/A 64910322 00889024379718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown