BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM DIST REAMER EXTENSION

    MDR report key: 3212396 · Received July 9, 2013

    Report

    Report Number
    1818910-2013-20723
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE CONFIRMS THE MATERIAL FRACTURE. PREVIOUS INVESTIGATION HAS CONFIRMED THE ISSUE OF INSTRUMENT BREAKAGE IN THE FORM OF TAB FRACTURE. A SEARCH OF THE COMPLAINTS DATABASES HAS IDENTIFIED A TREND OF THIS ISSUE, REFERENCE (B)(4). 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 MARCH 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 AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    RECLAIM REAMER EXTENSION: BROKEN METAL TAB NOTICED WHILST PREPARING FOR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312554 RECLAIM DIST REAMER EXTENSION MANUAL INSTRUMENT LXH 1219655 DEPUY-RAYNHAM NB8018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other