BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE DRIVER & FIXATION DRILL

    MDR report key: 656665 · Received December 22, 2005

    Report

    Report Number
    656665
    Event Type
    Malfunction
    Date Received
    December 22, 2005
    Date of Event
    November 22, 2005
    Report Date
    December 2, 2005
    Manufacturer
    LINVATEC CORP.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MICROCHOICE WIRE DRIVER & FIXATION DRILL, PRODUCT NUMBER 5020-027, WAS USED TO SCREW A BIT INTO LEFT KNEE. DRILL WAS PUT IN REVERSE TO EXTRACT BIT AFTER IT WAS INSERTED TO PROPER DEPTH AND BIT CONTINUED IN FORWARD DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE DRIVER & FIXATION DRILL ORTHOPEDIC DRILL HTW LINVATEC CORP. 5020-027 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR