BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH CAPACITY NARROW INTRAMEDULLARY TIP

    MDR report key: 17807045 · Received September 25, 2023

    Report

    Report Number
    0001526350-2023-01188
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 2, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    UDI-DI
    00889024374966
    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 EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, B5, D2, D4, G1, G3, G6, H1, H2, H3, H4, H6, H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THERE WAS DEBRIS WITHIN THE SEALED PACKAGING. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CANNOT BE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR - 0001526350 - 2023 - 01184-1 MFR - 0001526350 - 2023 - 01185-1 MFR - 0001526350 - 2023 - 01186-1 MFR - 0001526350 - 2023 - 01187-1.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: JAPAN. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR - 0001526350-2023-01184. MFR - 0001526350-2023-01185. MFR - 0001526350-2023-01186. MFR - 0001526350-2023-01187.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING RECEIVING/INSPECTION THAT THE UNIT WAS OBSERVED TO HAVE DEBRIS IN THE PACKAGE. THERE WAS NO HARM OR INJURY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743367 HIGH CAPACITY NARROW INTRAMEDULLARY TIP LAVAGE HANDPIECE TIP FQH ZIMMER SURGICAL, INC. N/A 65925310 00889024374966

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose