BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDARTIS 18MM SCREW

    MDR report key: 22771403 · Received August 11, 2025

    Report

    Report Number
    MW5174304
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 5, 2025
    Manufacturer
    MEDARTIS, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONE 18MM SCREW BROKE OFF INTO THE LEFT RADIUS DURING SURGICAL PROCEDURE. HEAD OF SCREW RETRIEVED AND PLACED ON STERILE FIELD, HOWEVER THE SURGEON DETERMINED THAT IT WOULD CAUSE MORE DAMAGE TO TRY TO DRILL OUT THE REST OF THE SCREW SHAFT AND IT WAS LEFT IN THE RADIUS. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271010 MEDARTIS 18MM SCREW SCREW, FIXATION, BONE HWC MEDARTIS, INC. A-5750. 18/1

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other| R