BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WR SGL END TRCR TIP SMTH 1.1X100MM

    MDR report key: 24628844 · Received March 18, 2026

    Report

    Report Number
    3008650117-2026-00069
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 16, 2026
    Manufacturer
    PARAGON 28
    Product Code
    HXI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: EVENT OCCURRED IN CANADA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HEMIEPIPHYSIODESIS PROCEDURE, THE K-WIRE FRACTURED DURING DRILLING, AND THE FRACTURED PIECE WAS RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687294 K-WR SGL END TRCR TIP SMTH 1.1X100MM PASSER, WIRE, ORTHOPEDIC HXI PARAGON 28 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other