BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAVALORO-MORSE STERNAL RETRACTOR

    MDR report key: 2801217 · Received October 23, 2012

    Report

    Report Number
    1226348-2012-00516
    Event Type
    Injury
    Date Received
    October 23, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT TWO DEVICES WERE SENT TO THE SUPPLIER FOR EVALUATION. ONE OF THE RETURNED DEVICES WAS FOR COMPARISON ONLY; THE OTHER DEVICE IS SUBJECT OF THE COMPLAINT. IT WAS DETERMINED THAT THERE WAS A VALIDATED CHANGE IN SUPPLIER AS WELL AS A MINOR CHANGE OF THE DEVICE, WHICH INCREASED THE BEND OF THE RETRACTOR ARM. IT WAS NOTED THAT THE CHANGE DID NOT AFFECT THE FORM, FIT OR FUNCTION OF THE DEVICE. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    SUPPLIER REPORTED THAT THE CUSTOMER USED THE DEVICE DURING A SURGICAL PROCEDURE AND NOTICED A DIFFERENCE BETWEEN THE RETRACTOR ARM LENGTHS AND MORE OF A PRONOUNCED BEND IN THE RETRACTOR ARM MANUFACTURED BY SUPPLIER. SINCE THE SURGEON WAS NOT COUNTING ON THE INCREASED BEND IN THE RETRACTOR ARM THE RETRACTOR DUG IN DEEPER THAN EXPECTED AND THEY CRACKED THE PATIENTS STERNUM. THIS ISSUE DID NOT ADD TIME TO THE SURGERY AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAVALORO-MORSE STERNAL RETRACTOR MANUAL SURGICAL INSTRU FOR GENERAL USE GAD CODMAN AND SHURTLEFF - RAYNHAM 117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention