BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECLAIM DIST REAMER EXTENSION

    MDR report key: 2933691 · Received January 29, 2013

    Report

    Report Number
    1818910-2013-11638
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES 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). 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 (B)(4).

    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

    DURING DISTAL REAMING USING RECLAIM, THE TABS FRACTURED OFF OF REAMER HANDLES ON BOTH INSTRUMENTS (BOTH TABS, ALSO). ALL 4 TABS WERE RETRIEVED. THIS RENDERED BOTH HANDLES INOPERATIVE AND PREVENTED CONTINUED REAMING, CAUSING A SURGICAL DELAY OF 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39245 RECLAIM DIST REAMER EXTENSION HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. NB8019

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention