BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE 10/10 LENGTH 1000MM ONE BLUNT TIP

    MDR report key: 3349452 · Received August 9, 2013

    Report

    Report Number
    9615741-2013-00035
    Event Type
    Malfunction
    Date Received
    August 9, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 9, 2013
    Manufacturer
    NEWDEAL S.A.S
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON USED A K-WIRE DURING FOOD SURGERY TO PIN A UNI-CP PLATE IN ORDER TO TEMPORARILY HOLD IT IN PLACE. WHEN THE SURGEON ATTEMPTED REMOVAL OF THE K-WIRE, THE END SHEARED OFF INSIDE THE BONE. APPROX 1 CENTIMETER OF THE K-WIRE WAS BROKEN OFF IN THE BONE. THE SURGEON USED A RONGEUR TO RETRIEVE THE BROKEN K-WIRE OUT OF THE PT. NO K-WIRE WAS LEFT IN THE PT. THERE WAS NO INJURY ALLEGED AND THE SURGERY WAS DELAYED BY 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380995 K-WIRE 10/10 LENGTH 1000MM ONE BLUNT TIP HALLU-FIX HTY NEWDEAL S.A.S

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR