BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT MULTI DIRECT 2.0MM

    MDR report key: 2023405 · Received March 2, 2011

    Report

    Report Number
    1818910-2011-03479
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, PREVIOUS INVESTIGATIONS FOUND PRODUCT DEVELOPMENT DESIGNED A NEW INSERT VIA (B)(4) IMPLEMENTED ON (B)(6) 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. THIS PRODUCT CODE IS NOW DISCONTINUED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    SHAFT SHEARED OFF WHILE INSERTING SCREW IN CENTRAL PROXIMAL HOLE OF DVRANSR PLATE. THE SHAFT FRAGMENT REMAINS FLUSH WITH THE PLATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA