BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT MULTI DIRECT 2.0MM

    MDR report key: 2172615 · Received July 19, 2011

    Report

    Report Number
    1818910-2011-12559
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PREVIOUS INVESTIGATIONS FOUND PRODUCT DEVELOPMENT DESIGNED A NEW INSERT VIA ECO# 280824 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 CHANGES OF BREAKAGES. THIS PRODUCT CODE IS NOW DISCONTINUED. IN ADDITION, THE PROVIDED LOT NUMBER 31080603 INDICATES THE PRODUCT WAS MFG IN AUGUST OF 2006 AND IS ALMOST 5 YEARS OLD. A TWO-YEAR SEARCH OF THE NEW PRODUCT CODE FOUND NO REPORTS FOR TIPS BREAKING. 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

    DURING SURGERY, THE TIP OF THE SCREWDRIVER 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 31080603

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention