BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL SPIKE Y-CONN. SET, PKG'D

    MDR report key: 18647856 · Received February 5, 2024

    Report

    Report Number
    0001526350-2024-00193
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Report Date
    March 13, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    UDI-DI
    00889024374928
    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 COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). A FOLLOW UP/ FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE G2: FOREIGN COUNTRY - JAPAN MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2024-00194 0001526350-2024-00195 0001526350-2024-00196 0001526350-2024-00197.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2024-00194-1 0001526350-2024-00195-1 0001526350-2024-00196-1 0001526350-2024-00197-1 VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED A LOOSE HAIR-LIKE PARTICULAR WITHIN THE STERILE PACKAGING. THE PACKAGING DID NOT MEET THE ACCEPTANCE CRITERIA PER ZPO 8.400 PACKAGING MATERIALS INSPECTION. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. 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 THAT THERE WAS A HAIR-LIKE SUBSTANCE IN THE PACKAGE. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463197 DUAL SPIKE Y-CONN. SET, PKG'D LAVAGE,JET FQH ZIMMER SURGICAL, INC. N/A 65925286 00889024374928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose