BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TPRD HEX SCDR U-JOINT

    MDR report key: 3961656 · Received July 28, 2014

    Report

    Report Number
    1818910-2014-24271
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 28, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORTED EVENT; HOWEVER UPON FURTHER EXAMINATION OF THE DEVICE, A PORTION OF THE U-JOINT BODY WAS FOUND TO BE FRACTURED. THE FRACTURED PIECE WAS NOT RETURNED FOR EXAMINATION. REQUESTS FOR ADDITIONAL INFORMATION WAS UNSUCCESSFUL. PREVIOUS INVESTIGATIONS FOUND THE ROOT CAUSE IS ATTRIBUTED TO THE SUPPLIER¿S HEAT TREATING PROCESS; CORROSION FOUND WITH CARBIDE EMBRITTLEMENT AS A POSSIBLE CONTRIBUTING FACTOR. IMPROVEMENTS TO THE HEAT TREATING PROCESS HAVE BEEN RECOGNIZED AND A SUPPLIER CHANGE REQUEST TO HEAT TREAT ALL 400 SERIES STAINLESS STEEL COMPONENTS IN THE UNITED STATES HAS BEEN IMPLEMENTED AND RELEASED. SCR-002557 RELEASED 10/03/2012 TO REQUEST THE USE OF AN ALREADY APPROVED HEAT TREAT SUPPLIER, LAKE CITY HEAT TREAT. MONITOR THROUGH TREND ANALYSIS. THE DATE CODE A0209 INDICATES THE INSTRUMENT WAS MANUFACTURED IN FEBRUARY OF 2009 AND WAS MANUFACTURED PRIOR TO THE CHANGES. NO FURTHER ACTION INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    HEX SCREWDRIVER FROM QUICKSET GRATER INSTRUMENT TRAY HAD A FAULTY (UNSTABLE) CONNECTION TO THE HANDLE OF RATCHET DRIVER. UPDATE (B)(4) 2014 UPON FURTHER INVESTIGATION OF THE PRODUCT, IT WAS DISCOVERED THE INSTRUMENT BROKE AT THE U-JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439427 QUICKSET TPRD HEX SCDR U-JOINT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. A0209

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR