BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 IM ROD 400MM

    MDR report key: 3102769 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16833
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS INSTRUMENT BREAKAGE. A SEARCH OF THE COMPLAINTS DATABASES HAS IDENTIFIED A TREND OF THIS ISSUE. ECO412859 WAS IMPLEMENTED ON JANUARY 16, 2013 TO REMOVE THE CUSTOM 455 SS MATERIAL FROM DEPUY DRAWING DWG-13760040. A MEDICAL DEVICE CORRECTION NOTICE WAS DISTRIBUTED ON FEBRUARY 05, 2013 AND MARCH 11, 2013 FOR SPECIFIC LOTS OF THE 966120 PRODUCT CODE. THE NOTICE INDICATED THAT DEPUY HAS IDENTIFIED THE POTENTIAL FOR THE SP2 IM ROD TO FAIL DUE TO FATIGUE WHEN EXCESS LEVERAGE IS APPLIED AT THE TIP. SURGICAL TECHNIQUES WERE UPDATED AND TECHNICAL POINTS WERE EMPHASIZED THAT MAY FURTHER REDUCE THE INCIDENCE OF TIP FRACTURE IN THE COMMUNICATION. THE ROOT CAUSE IS ATTRIBUTED TO DESIGN. 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

    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

    IM ROD BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204348 SP2 IM ROD 400MM KNEE INSTRUMENT LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS H0309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention