BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDL 10PK

    MDR report key: 25045793 · Received April 30, 2026

    Report

    Report Number
    0001825034-2026-01162
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 30, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    DZL
    UDI-DI
    00880304523401
    PMA / PMN Number
    K140908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 912084, JGRKNT 1.0MM MINI 3-0 NDL 10PK, LOT # 0002726981. G2: FOREIGN, EVENT OCCURRED IN (B)(6). THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FORK-SHAPED COMPONENTS ON TWO CONSECUTIVE UNITS FRACTURED. NO FOREIGN BODY RESIDUE WAS OBSERVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397629 JGRKNT 1.0MM MINI 3-0 NDL 10PK SCREW, FIXATION, INTRAOSSEOUS DZL ZIMMER BIOMET, INC. 0002726981 00880304523401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.