BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLINS RADIOPARENT BLADE

    MDR report key: 2488506 · Received March 12, 2012

    Report

    Report Number
    1226348-2012-00126
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 12, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    DWH
    PMA / PMN Number
    K904352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE WHEN THE BLADES WERE INSERTED INTO THE RETRACTOR BODY AND SPREAD WITH MINOR FORCE, ONE OF THE TWO BLADES BROKE IN PIECES, THE STERNUM CLOSED SUDDENLY. AFFILIATE ALSO REPORTED THE TEXTURE OF THE BLADES APPEARED TO BE DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLINS RADIOPARENT BLADE BLADE, SAW, SURGICAL, CARDIOVASCULAR DWH CODMAN AND SHURTLEFF - RAYNHAM 123831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown