BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISION

    MDR report key: 22166379 · Received June 9, 2025

    Report

    Report Number
    22166379
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 22, 2025
    Report Date
    June 5, 2025
    Manufacturer
    MEDARTIS INC
    Product Code
    HTW
    UDI-DI
    00810041061737
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WENT TO THE OPERATING ROOM FOR A ORIF [OPEN REDUCTION AND INTERNAL FIXATION], RIGHT METACARPAL FRACTURE. MEDARTIS KIT WAS USED FOR IMPLANTS. DURING THE PROCEDURE FOUR DIFFERENT DRILL BITS BROKE AND BECAME STUCK INSIDE THE PATIENT. SURGEON WAS ABLE TO REMOVE TWO OF THEM, HOWEVER TWO PIECES OF DRILL BIT REMAINED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265388 PROVISION BIT, DRILL HTW MEDARTIS INC A-3230 00810041061737

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female