BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, 1.2 THREAD DIAM, 21 THREAD LENGTH

    MDR report key: 525130 · Received February 13, 2004

    Report

    Report Number
    9680825-2004-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    November 21, 2003
    Report Date
    February 13, 2004
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING AN ELBOW FRACTURE FIXATION USING PARTIALLY-THREADED GUIDE WIRES, TWO WIRES BROKE AS THE SURGEON ATTEMPTED TO EXTRACT AND RELOCATE THE WIRES. AS A RESULT OF THIS BREAKAGE, TWO THREADED PORTIONS OF THE WIRE REMAINED IN SITU. THE REMOVED SECTIONS OF WIRES WERE DISPOSED OF IN A 'SHARP BIN' BY HOSP STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, 1.2 THREAD DIAM, 21 THREAD LENGTH EXTERNAL FIXATION JEC ORTHOFIX SRL W1221 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *