BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE 10/10 LENGTH 100 MM

    MDR report key: 2122047 · Received May 24, 2011

    Report

    Report Number
    9615741-2011-00022
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTEGRA, SAINT PRIEST
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING AN AKIN OSTEOTOMY SURGICAL PROCEDURE FOR HALLUX VALGUS, THE KIRSCHNER WIRE BROKE OFF IN THE PT'S BONE WHEN THE SURGEON WAS PLACING THE SCREW. THE BROKEN FRAGMENT WAS RECOVERED DURING THE PROCEDURE AND THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE 10/10 LENGTH 100 MM ORTHO FIXATION HWC INTEGRA, SAINT PRIEST

    Patients

    Seq Age Sex Outcome Treatment
    1