BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM DIST REAMER EXTENSION

    MDR report key: 4093837 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28220
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 27, 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 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 (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 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

    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 (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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY..

    Description of Event or Problem · 1

    THREADING/PIECES ON END USED TO GRAB REAMER ARE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571369 RECLAIM DIST REAMER EXTENSION HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. NB8016

    Patients

    Seq Age Sex Outcome Treatment
    1