BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYOUT

    MDR report key: 2090738 · Received April 27, 2011

    Report

    Report Number
    1818910-2011-05669
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVISE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. REPEATED ATTEMPTS TO OBTAIN THE COMPLAINT SAMPLES PROVED UNSUCCESSFUL. BASED ON PREVIOUS CONVERSATIONS WITH DEPUY MIAMI TRAUMA CONCERNING THE NEED FOR A PRA (PATIENT RISK ASSESSMENT) THE FOLLOWING WAS NOTED: AN EXTENSIVE REVIEW OF THE MEDICAL FRAGMENT ISSUE AND PUT A DHF AMENDMENT IN THE ENTIRE TRAUMA DHFS DISCUSSING THE RISKS AND HAZARDS ASSOCIATED WITH MEDICAL FRAGMENTS. THIS ASSESSMENT WAS THEN CARRIED INTO THE UPDATED DFMEAS THAT WERE COMPLETED IN EARLY 2010 THAT COVER ALL TRAUMA PRODUCTS. THE RISK WAS CONSIDERED A BROADLY ACCEPTABLE WITH NO FURTHER ACTION REQUIRED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE DEVICE WAS USED TO REMOVE THE SCREWS WHICH WERE IMPLANTED IN MALLEOLUS MEDIALIS IN THE REVISION SURGERY SINCE THE PATIENT WAS HEALED. WHEN THE SURGEON TRIED TO REMOVE THE SCREW, IT WAS TOO DIFFICULT TO REMOVE AND THE DEVICE WAS BROKEN DURING SURGERY. THE SCREW AND THE BROKEN PART OF THE DEVICE WERE LEFT IN THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYOUT 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR