BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE PIN ASSEMBLY 4.5MM

    MDR report key: 1171270 · Received September 19, 2008

    Report

    Report Number
    1818910-2008-04027
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDW
    PMA / PMN Number
    K991649
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE AS400 FOUND 30 PIECES WERE RELEASED FOR DISTRIBUTION IN 2007. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MANUFACTURING DEVIATIONS AND/OR ANOMALIES. THE RECORDS SHOW THIS LOT WAS STERILIZED PRIOR TO RELEASE FOR DISTRIBUTION. 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. SHOULD THE PRODUCT AND/OR 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 PATIENT WAS REVISED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVICLE PIN ASSEMBLY 4.5MM 87JDW JDW DEPUY ORTHOPAEDICS, INC. NA B33HL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention