BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 18913283 · Received March 14, 2024

    Report

    Report Number
    MW5152866
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    March 8, 2024
    Report Date
    March 12, 2024
    Manufacturer
    MEDARTIS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRIVER BIT BROKE. ALL PIECES RECOVERED. NO HARM DONE TO PATIENT. CHARGE NURSE INFORMED. PIECE GIVEN TO (B)(6), CLINICIAN. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185089 DRILL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDARTIS INC. A-2013 20215662

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male