BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "1.5MM" SYSTEM 1.5X6MM HT SD X-DR SCR

    MDR report key: 15977535 · Received December 14, 2022

    Report

    Report Number
    0001032347-2022-00380
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    October 6, 2021
    Report Date
    December 14, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053758
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #91-6106, LOT #J398520; "1.5MM" SYSTEM 1.5X6MM HT SD X-DR SCR QTY 5. ITEM #91-6107, LOT #991620; "1.5MM" SYSTEM 1.5X7MM HT SD X-DR SCR EA. FOREIGN SOURCE: COLOMBIA. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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: 0001032347-2022-00374; 0001032347-2022-00375; 0001032347-2022-00376; 0001032347-2022-00377; 0001032347-2022-00378; 0001032347-2022-00379.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THAT THE SCREWS FRACTURED AT THE SCREW HEAD WHEN THEY WERE BEING IMPLANTED. THIS RESULTED IN A DELAY IN PROCEDURE OF APPROXIMATELY 30 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476655 "1.5MM" SYSTEM 1.5X6MM HT SD X-DR SCR PLATE, BONE JEY BIOMET MICROFIXATION N/A J398520 00841036053758

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Unknown