BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM DRILL WITH DEPTH STOP

    MDR report key: 1983710 · Received February 10, 2011

    Report

    Report Number
    1219602-2011-00003
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    November 4, 2010
    Report Date
    December 10, 2010
    Manufacturer
    SMITH & NEPHW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT INDICATES THAT TWO DRILL BITS BROKE OFF IN THE PATIENTS BONE AND REMAIN IN THE BONE. NO HARM TO PATIENT. USER FACILITY REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.7MM DRILL WITH DEPTH STOP DRILL, WITH DEPTH STOP, 2.7MM HTW SMITH & NEPHW ENDOSCOPY MANSFIELD MANUFACTURE 72201918 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR