BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT MINI; DRILL BIT SHORT

    MDR report key: 1942046 · Received November 9, 2010

    Report

    Report Number
    1722511-2010-00008
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. NO DIRECT CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING SURGERY, 2 SMALL DRILL BITS BROKE OFF AS SURGEON WAS DRILLING. ALL PORTIONS OF THE BROKEN BITS WERE RETRIEVED, AND A MEDIUM BIT WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER REPORTED INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT MINI; DRILL BIT SHORT DRILL BITS HTW ORTHO DEVELOPMENT CORP. 228-0021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention