BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET

    MDR report key: 14676223 · Received June 10, 2022

    Report

    Report Number
    MW5110258
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ZIMMER BIOMET
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ZIMMER BIOMET 1/8X3.2 DRILL BIT REF# 32-486265. TIP BROKE OFF IN PT'S RIGHT FEMUR. POSTOP XRAY CONFIRMED THAT THE FOREIGN OBJECT WAS RETAINED IN DISTAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687685 ZIMMER BIOMET BIT, DRILL HTW ZIMMER BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female