BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE 10/10 - LENGTH 70 MM

    MDR report key: 2078210 · Received April 8, 2011

    Report

    Report Number
    9615741-2011-00020
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 8, 2011
    Manufacturer
    INTEGRA, SAINT PRIEST
    Product Code
    DZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A K-WIRE (KIRSCHNER WIRE) BROKE DURING A SURGICAL PROCEDURE. THE PATIENT'S BONE WAS VERY HARD AND THE DRILL SHEARED OFF THE K-WIRE. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE 10/10 - LENGTH 70 MM NA DZK INTEGRA, SAINT PRIEST UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NOT APPLICABLE.