BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE PIN ASSEMBLY 2.5MM

    MDR report key: 1053597 · Received May 22, 2008

    Report

    Report Number
    1818910-2008-01701
    Event Type
    Injury
    Date Received
    May 22, 2008
    Report Date
    April 23, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PIN BY A DEPUY WARSAW MATERIAL RESEARCH MANAGER CONFIRMED THE FRACTURE. BENT PLASTIC DEFORMATION IS NOTED ALONG THE TROCHAR END OF THE SMALL THREADED REGION. ALONG THE CREST OF THE BEND, AN ORIGINATION SITE IS SHOWN SUGGESTING THE PIN FRACTURED IN BENDING. NO MATERIAL ANOMALIES WERE OBSERVED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. 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 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. ALL PIECES WERE REMOVED BUT THERE WAS A 20-30 MIN DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVICLE PIN ASSEMBLY 2.5MM 87JDW JDW DEPUY ORTHOPAEDICS, INC. NA B4KD21000

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR