BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT MULTI DIRECT 2.0MM

    MDR report key: 1585303 · Received January 13, 2010

    Report

    Report Number
    1818910-2009-08184
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED, 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 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 INVESTIGATION WAS LIMITED TO REVIEW OF THE INFO PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE INSPECTION RECORDS AND TO DETERMINE THE AGE OF THE INSTRUMENT WAS NOT PROVIDED. IT IS UNKNOWN IF THE COMPLAINT SAMPLE WAS MANUFACTURED BEFORE OR AFTER THE CHANGES. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE INSERT TIP BROKE OFF IN THE MDTP SCREW HEAD. THE TIP IS STUCK IN THE SCREW AND COULD NOT BE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR