BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-CONDL CHISEL 8X10X7 3/4 IN

    MDR report key: 3994188 · Received August 8, 2014

    Report

    Report Number
    1818910-2014-25274
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMS THE REPORT. PREVIOUS EXAMINATION BY THE DEPUY WARSAW MATERIAL RESEARCH DEPARTMENT OF THE PRODUCT CODE 242101000 DETERMINED THE FRACTURE OF THE CHISELS IS CAUSED BY DUCTILE OVERLOAD. FRACTURE DUE TO OVERLOAD INDICATED THAT SINGLE FORCE WAS APPLIED EXCEEDING THE ULTIMATE STRENGTH OF THE MATERIAL. NO MATERIAL DEFECTS WERE OBSERVED IN THE CHISEL THAT COULD HAVE CONTRIBUTED TO FRACTURE INITIATION AND/OR PROPAGATION TO FAILURE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE TIP OF THE CHISEL SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468094 IN-CONDL CHISEL 8X10X7 3/4 IN GENERAL/MISC INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. SO2008164

    Patients

    Seq Age Sex Outcome Treatment
    1