BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 24229108 · Received February 2, 2026

    Report

    Report Number
    0001825034-2026-00260
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    July 26, 2024
    Report Date
    January 30, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    DZL
    UDI-DI
    00880304523418
    PMA / PMN Number
    K140908
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. D4: THE CUSTOMER PROVIDED THE POSSIBLE LOT COMBINATIONS: LOT: 0002508627. MANU DATE: MAR 23, 2023. EXPIRATION DATE: MAR 23, 2028. UDI: ((B)(4). LOT: 0002508605. MANU DATE: MAR 21, 2023. EXPIRATION DATE: MAR 21, 2028. UDI: (B)(4). LOT: 0002547208. MANU DATE: AUG 28, 2023. EXPIRATION DATE: AUG 28, 2028. UDI: ((B)(4). LOT: 0002554458. MANU DATE: SEP 29, 2023. EXPIRATION DATE: SEP 29, 2028. UDI: (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY FOR A DORSAL DISLOCATION OF THE LEFT LITTLE FINGER, THE TIP OF AN INSERTER FRACTURED AND A FRAGMENT REMAINED IN THE OPERATIVE SITE, WHICH WAS NOT RECOGNIZED INTRA-OPERATIVELY. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISCOMFORT AT THE OPERATED SITE AND PRESENTED TO THE HOSPITAL. THE SURGEON CONFIRMED A RETAINED FRACTURED INSERTER FRAGMENT BY RADIOGRAPHIC IMAGING, AND THE RELATIONSHIP BETWEEN THE PATIENT¿S DISCOMFORT AND THE RETAINED FRAGMENT WAS UNCLEAR. THERE WAS NO PLAN FOR RE-OPERATION AT THAT TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291642 JGRKNT 1.0MM MINI 3-0 NDLS SCREW, FIXATION, INTRAOSSEOUS DZL ZIMMER BIOMET, INC. 0002508627 00880304523418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other