BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT MULTI DIRECT 2.0MM

    MDR report key: 1590855 · Received January 26, 2010

    Report

    Report Number
    1818910-2010-00163
    Event Type
    Injury
    Date Received
    January 26, 2010
    Report Date
    January 8, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT CONFIRMED A PORTION OF THE TIP BROKE OFF. PREVIOUS INVESTIGATIONS FOUND PRODUCT DEVELOPMENT DESIGNED A NEW INSERT VIA (B) (4) IMPLEMENTED ON 11/25/2008. THE NEW DRIVER HAS A DIFFERENT PRODUCT NUMBER (2312-11-002). THE DIFFERENCE BETWEEN THE EXISTING DRIVER 2312-11-020 AND THE NEW DRIVER IS THAT THE NEW DRIVER WAS DESIGNED TO MATE WITH THE MQC HANDLE THAT IS CURRENTLY BEING USED FOR THE INSERTION OF THE OTHER PEGS AND PEG SCREWS. BY MATING TO THE MQC HANDLE, THE AMOUNT OF TORQUE THAT CAN BE TRANSFERRED TO THE MDTP IS GREATLY REDUCED COMPARED TO THE EXISTING HANDLE. THIS REDUCES THE POTENTIAL RISK OF THE TIP OF THE DRIVER BREAKING OFF DURING MDTP INSERTION, WHILE STILL PROVIDING THE REQUIRED TORQUE TO FULLY SEAT THE MDTP INTO THE PLATE. BESIDES MATING TO THE MQC, THE NEW DRIVER CAN ALSO BE IDENTIFIED BY ITS GOLD TIP. IN ADDITION, THE NEW INSERT TIP IS COATED WITH PVD (PHYSICAL VAPOR DEPOSITION) WITH TITANIUM NITRIDE TO MAKE THE TIP STRONGER AND REDUCE CHANCES OF BREAKAGES. THE COMPLAINT SAMPLE IS THE OLD STYLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE AND WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERT MULTI DIRECT 2.0MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA 31080601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA