BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET SCREWDRIVER

    MDR report key: 8864828 · Received August 5, 2019

    Report

    Report Number
    MW5088771
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREWDRIVER TIP BROKE OFF DURING SURGERY AND REMAINED IN SCREW BED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656679 ZIMMER BIOMET SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER, INC. 14-441043

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR