BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT SINGLE 1.4MM 1 #1 MB

    MDR report key: 10800494 · Received November 6, 2020

    Report

    Report Number
    0001825034-2020-04021
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    November 3, 2020
    Report Date
    May 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K150768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE TIP AS WELL AS THE SUTURE OF THE JUGGERKNOT HAD FRACTURED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 912030 JGRKNT SINGLE 1.4MM 1 #1 MB P13368; 912030 JGRKNT SINGLE 1.4MM 1 #1 MB P13368. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04020, 0001825034 - 2020 - 04022.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FRACTURED WHILE TRYING TO IMPLANT THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266378 JGRKNT SINGLE 1.4MM 1 #1 MB FASTENER, FIXATION MBI ZIMMER BIOMET, INC. P13368

    Patients

    Seq Age Sex Outcome Treatment
    1