BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE PIN ASSEMBLY 2.5MM

    MDR report key: 2151329 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11839
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDW
    PMA / PMN Number
    K103001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MFG DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. A PREVIOUS INVESTIGATION FOUND PRODUCT DEVELOPMENT, MARKETING, AND SURGEON INPUT HAS DETERMINED THAT THE 2.5MM PIN NEEDS TO HAVE A SHORT VERSION FOR SMALL PTS TO HELP PREVENT BREAKAGES. (B)(4) WAS INITIATED ON JUL 28TH, 2009 TO ADDRESS THE CORRECTIVE ACTIONS. (B)(4) WAS COMPLETED ON JUN 10, 2011. THE NEW PART NUMBER FOR THE SHORTER VERSION PIN IS (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE CLAVICLE PIN BROKE DURING INSERTION. THE SURGERY WAS EXTENDED APPROX 30-45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVICLE PIN ASSEMBLY 2.5MM 87JDW JDW DEPUY ORTHOPAEDICS, INC. NA 101793

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR