BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE THREADS ROUND HEAD SCREW

    MDR report key: 1051550 · Received May 16, 2008

    Report

    Report Number
    1825034-2008-00118
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    May 5, 2006
    Report Date
    May 8, 2006
    Manufacturer
    ARTHROTEK/BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    K982497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. EVAL OF RETURNED DEVICE DETERMINED CONDITION WAS A RESULT OF INCOMPLETE TRIMMING OF THE GATE FOLLOWING INJECTION MOLD. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED. THIS REPORT FILED ON MAY 16, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE IN 2006, THE HEAD OF THE GENTLE THREAD SCREW WAS ROUGH CAUSING IT TO CATCH AND FRAY THE GRAFT WHEN INSERTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLE THREADS ROUND HEAD SCREW HWC ARTHROTEK/BIOMET, INC. NA 141700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK