BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEX SCREWDRIVER

    MDR report key: 7454158 · Received April 24, 2018

    Report

    Report Number
    7454158
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 18, 2018
    Manufacturer
    ZIMMER INC. (BIOMET 3I, LLC )
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF SCREWDRIVER BROKE OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296446 LARGE HEX SCREWDRIVER SCREWDRIVER HXX ZIMMER INC. (BIOMET 3I, LLC ) 4812-45 56491765

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR