BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 IM ROD 400MM

    MDR report key: 1022125 · Received March 26, 2008

    Report

    Report Number
    1818910-2008-00824
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED ROD CONFIRMED THE REPORTED BREAKAGE. THE PRODUCT RETURNED IS OF A PRIOR DESIGN. A CONCLUSIVE ROOT CAUSE WAS NOT IDENTIFIED. ALTHOUGH THE DESIGN HAS BEEN ENHANCED SINCE THE COMPLAINT SAMPLE WAS MANUFACTURED, THE ROD BREAKAGE MAY ALSO BE RELATED TO A COMBINATION OF INSTRUMENT AGE, SVC LIFE, AND/OR USER TECHNIQUE. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN RESPONSE TO A TREND IDENTIFIED PREVIOUSLY FOR THIS PRODUCT CODE, ECO 38013 WAS RELEASED IN 2001, CHANGING THE RAW MATERIAL USED AND THE GEOMETRY OF THE ROD. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY COMPLAINT OF THIS NATURE MANUFACTURED AFTER THIS CHANGE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING SURGERY, THE IM ROD BROKE OFF INTO THE FEMUR. A PIECE APPROX 3 1/2 INCHES LONG HAD TO BE LEFT IN THE PT. THE ROD BROKE JUST BELOW THE SCREW THAT IS IN THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SP2 IM ROD 400MM 87LXH LXH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR