BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCR 42MM

    MDR report key: 1011447 · Received March 11, 2008

    Report

    Report Number
    1818910-2008-00771
    Event Type
    Injury
    Date Received
    March 11, 2008
    Report Date
    February 26, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K871539
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. ACE LELOCLE SARL REVIEWED THE DEVICE HISTORY RECORDS FOR LOT DCBB39 AND FOUND NO DISCREPANCIES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT SB2117 FOUND NO MFG DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ANY ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT HAD A PAIN AFTER DISCHARGE. AFTER THE DISCHARGE, IT WAS FOUND THROUGH X-RAY PICTURE THAT THE SCREWS USED FOR THE DISTAL SCREW HOLES OF THE NAIL WERE BROKEN. THERE IS NO PLAN FOR ANOTHER SURGERY AT THIS MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL BONE SCR 42MM 87HSB HSB DEPUY ACE S.A. 'R.L. NA DCBB39

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR