BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 562733 · Received November 11, 2004

    Report

    Report Number
    MW1033808
    Event Type
    Malfunction
    Date Received
    November 11, 2004
    Date of Event
    October 7, 2004
    Report Date
    November 11, 2004
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILURE - BROKE APART.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/15/05: MFR HAS RECEIVED LETTER DATED JAN. 2005, REGARDING THE NEW DEAL KALIX SCREW, CATALOG #140010ND, LOT #B085. THIS PRODUCT IS NOT MANUFACTURED BY WRIGHT MEDICAL TECHNOLOGY, INC. NEW DEAL IS THE MANUFACTURER AND HAS AGREED TO FORWARD THIS MATTER TO THE APPROPRIATE DEPT.

    Description of Event or Problem · 1

    A FDA LETTER, REPORT NUMBER MW1033808, DATED 1/26/2005 WAS RECEIVED TO INTEGRA LIFESCIENCES COMPLAINT OFFICE ON 4/26/2005. WRIGHT MEDICAL FORWARDED THE LETTER TO NEWDEAL. THIS LETTER WAS ORIGINALLY SENT TO WRIGHT MEDICAL TECHNOLOGY, INC. THE FORMER DISTRIBUTOR OF NEWDEAL PRODUCT IN THE US. INTEGRA LIFESCIENCES HAS ACQUIRED NEWDEAL. INITIAL INCIDENT INFORMATION WAS SENT TO WRIGHT MEDICAL TECHNOLOGY BY THE USER FACILITY. WRIGHT MEDICAL TECHNOLOGY DID NOT REGARD THE COMPLAINT AS A MEDICAL DEVICE REPORTABLE EVENT, HOWEVER, INTEGRA LIFESCIENCES AS THE NEW MANUFACTURER REPRESENTATIVE OF NEWDEAL CONSIDERED THE COMPLAINT MDR REPORTABLE, AND FILED A MDR TO FDA. THE MDR NUMBER WAS 9615741-2005-00004. THE CATALOG NUMBER IS 140010. THE LOT NUMBER IS B085. THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND NO ANOMALY WAS FOUND. DEVICE WAS RELEASED WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SUB TAYLOR ARTHROTHESIS HWL WRIGHT MEDICAL TECHNOLOGY, INC. NOT AVAILABLE B085

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR