BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECLAIM DIST REAMER EXTENSION

    MDR report key: 3011289 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-13286
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED INSTRUMENT BREAKAGE IN THE FORM OF TAB FRACTURE. A SEARCH OF THE COMPLAINTS DATABASES HAS IDENTIFIED A TREND OF THIS ISSUE, REFERENCE (B)(4). PREVIOUS 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. (B)(4) 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 (B)(4).

    Description of Event or Problem · 1

    FLANGE FELL OFF WHILE REAMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114412 RECLAIM DIST REAMER EXTENSION HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 NB12653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention