BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX, 4.5MM CANN. ENDOSCOPIC DRILL

    MDR report key: 285315 · Received July 7, 2000

    Report

    Report Number
    1219602-2000-00052
    Event Type
    Malfunction
    Date Received
    July 7, 2000
    Date of Event
    May 9, 2000
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO DRILL BITS WERE BROKEN BY A SURGEON DURING USE IN ONE PT. METAL FRAGMENTS WERE LEFT IN THE JOINT HOWEVER NO PT INJURY WAS REPORTED AS A RESULT OF THIS SITUATION. SMITH & NEPHEW, INC.-ENDOSCOPY DIVISON IS REPORTING THIS ON TWO MEDWATCH REPORTS 00-00051 & 00-00052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX, 4.5MM CANN. ENDOSCOPIC DRILL DRILL BIT HTW SMITH & NEPHEW, INC. ENDOSCOPY DIVISION NA 130229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN