BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SCREWDRIVER 2.5/2.8

    MDR report key: 15003328 · Received July 12, 2022

    Report

    Report Number
    MW5110825
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 8, 2022
    Manufacturer
    MEDARTIS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING DISTAL RADIUS ORIF (OPEN REDUCTION AND INTERNAL FIXATION) PROCEDURE A SCREWDRIVER TIP BROKE OFF THE END OF THE SCREWDRIVER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062702 POWER SCREWDRIVER 2.5/2.8 BILL, DRILL HTW MEDARTIS, INC. A-2013 1994340

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female