BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX

    MDR report key: 1126003 · Received August 18, 2008

    Report

    Report Number
    MW5008020
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 18, 2008
    Manufacturer
    R & M DISTRIBUTION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DRILL BIT PIN TIP RER AR-1590 LOT 116851 ARTHREX BROKE WHILE DRILLING DURING OR PROCEDURE. TIP OF DRILL RECOVERED AND VERIFIED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX DRILL BIT HRX R & M DISTRIBUTION RER AR1590 166851

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability