BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTICAL SCREW 38MM LGTH

    MDR report key: 2092827 · Received May 11, 2011

    Report

    Report Number
    1818910-2011-08320
    Event Type
    Injury
    Date Received
    May 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    HSB
    PMA / PMN Number
    K871539
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. (B)(4), THE MANUFACTURING FACILITY, STATED AT THE TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED. PROVIDED INFORMATION STATES THE FRACTURE WAS HEALED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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

    SCREW BREAKAGE WAS NOTED AFTER IMPLANTATION. REVISION WAS DONE DUE TO HEALED FRACTURE. TO REMOVE THE SCREW, TREPHINE WAS USED AND FIBULA WAS GROUND BY CHISEL. TIME OF THE SURGERY WAS DELAYED BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTICAL SCREW 38MM LGTH TRAUMA FIXATION HSB DEPUY INTERNATIONAL, LTD. NA DGNCMV

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention