BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT MULTI DIRECT 2.0MM

    MDR report key: 1645843 · Received March 18, 2010

    Report

    Report Number
    1818910-2010-01427
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 19, 2010
    Report Date
    February 19, 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
    CA, 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 PROVIDED PART AND LOT NUMBER INDICATE THE INSTRUMENT WAS MANUFACTURED PRIOR TO THE CHANGES. 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

    THE TIP OF THE SCREWDRIVER BROKE CAUSING A 45 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERT MULTI DIRECT 2.0MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA 31010803

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention