BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM DIST REAMER EXTENSION

    MDR report key: 3821456 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19130
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF THE TAB BREAKAGE. A SEARCH OF THE COMPLAINTS DATABASES HAS IDENTIFIED A TREND OF THIS ISSUE, REFERENCE (B)(4). PREVIOUS INVESTIGATION EVALUATION BY DEPUY METROLOGY, MATERIALS SCIENCE, PRODUCT DEVELOPMENT CONFIRMED THE ISSUE, BUT FOUND THE PRODUCT WAS MADE TO SPECIFICATIONS. A MEDICAL DEVICE CORRECTION NOTICE WAS DISTRIBUTED ON FEBRUARY 25, 2013 FOR ALL LOTS OF THE 2975-00-500 PRODUCT CODE MANUFACTURED SINCE DECEMBER 2011. THE NOTICE INDICATED THAT DEPUY HAS IDENTIFIED THE POTENTIAL FOR THE RECLAIM REAMER EXTENSION TABS TO BREAK. THE REAMER EXTENSIONS ARE NOT IMMEDIATELY BEING REMOVED FROM THE MARKET AND MAY CONTINUE TO BE USED UNTIL A DESIGN CHANGE IS IMPLEMENTED AND NEW DEVICES ARE AVAILABLE. ECO416771 DESIGN VALIDATION WAS IMPLEMENTED ON (B)(4) 2013. DEPUY PRODUCT DEVELOPMENT IS CURRENTLY IN PROCESS OF REDESIGNING THE INSTRUMENT TO UPDATE THE DESIGN AND BOLSTER ITS DURABILITY. THE ROOT CAUSE IS ATTRIBUTED TO DESIGN. MONITOR THROUGH TREND ANALYSIS PER SEP-419. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    ADDITIONAL NARRATIVE: 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

    INSTRUMENT BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299757 RECLAIM DIST REAMER EXTENSION HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 J0111

    Patients

    Seq Age Sex Outcome Treatment
    1