BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDARTIS 1.0MMX20MM, L76MM, A0 FIXATION

    MDR report key: 14160315 · Received April 18, 2022

    Report

    Report Number
    MW5109154
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 14, 2022
    Manufacturer
    MEDARTIS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PLACING ONE OF THE DISTAL SCREWS THE 1 MM DRILL BIT BROKE OFF IN THE SOFT TISSUES. THIS IS UNABLE TO EASILY GRAB FROM WITHIN THE METATARSAL WITHOUT CAUSING SIGNIFICANT AMOUNT OF FURTHER DAMAGE. WAS UNABLE TO FEEL THE DRILL BIT FROM THE BOTTOM OF THE FOOT AND OPTED TO LEAVE IT TO AVOID FURTHER DAMAGE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2716596 MEDARTIS 1.0MMX20MM, L76MM, A0 FIXATION BIT, DRILL HTW MEDARTIS, INC. A-3130 21267178

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male