BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATN LAG SCREW 100MM STERILE

    MDR report key: 2163066 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12377
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K042325
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE 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. PROVIDED INFORMATION STATES THE SURGEON REMOVED A 100MM LAG SCREW AND PUT IN A SHORTER ONE. THE FRACTURE WAS ALREADY HEALED SIGNIFICANTLY SO THE SURGEON DIDN'T WANT TO CHANGE THE NAIL OR POSITION. 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

    PATIENT WAS REVISED TO ADDRESS LAG SCREW CUT-OUT AND BACK-OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATN LAG SCREW 100MM STERILE 87HSB HSB DEPUY ACE S.A. 'R.L. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention