BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLINS RADIOPARENT BLADE

    MDR report key: 2488486 · Received March 12, 2012

    Report

    Report Number
    1226348-2012-00124
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 13, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    DWH
    PMA / PMN Number
    K904352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS INVESTIGATION AND DURING THE EVALUATION PROCESS IT WAS FOUND THAT MANY USED AND UNUSED BLADES WERE TESTED AND NONE OF WHICH COULD BE BROKEN AS DESCRIBED BY THE CUSTOMER. IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE; HOWEVER IT MIGHT BE LIKELY THAT THE BLADES WERE MIS-USED. THE SUPPLIER PERFORMED ADDITIONAL TESTING ON THE BLADES TO TRY AND DETERMINE THE ACTUAL FORCE NEEDED TO BREAK A BLADE. IT WAS ONLY POSSIBLE TO BREAK A BLADE WHEN THE BLADE WAS INSERTED INTO THE ACTUAL METAL DEVICE AT AN APPROXIMATE 30 DEGREE ANGLE. PRESSURE WAS APPLIED UNTIL THE BLADE BROKE. THE CALCULATION OF FORCE REQUIRED TO BREAK THE BLADE WAS IN EXCESS OF 250KG, FAR ABOVE THE CODMAN SPECIFICATION OF 60KG. IT WAS ALSO NOTED THAT THE BLADES RETURNED FROM THE CUSTOMER SHOWED EVIDENCE OF DISTORTION ON ONE OF TWO KEY RETAINING TABS. WE SUSPECT THE ONLY WAY THIS TAB CAN BE DISTORTED, IS FOR THE BLADE TO BE COCKED AT ANGLE. AS A RESULT IT IS LIKELY THAT THE BLADE WAS MIS-USED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS A REUSABLE PRODUCT.

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED CHANGING IN THE MEDWATCH TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED CHANGING IN THE MEDWATCH TO AN ADVERSE EVENT.

    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.

    Description of Event or Problem · 1

    THE BLADES WERE INSERTED INTO THE RETRACTOR BODY. WHEN OR-TEAM STARTED TO SPREAD (WITH A MINOR FORCE) ONE OF THE TWO BLADES BROKE TO PIECES, THE STERNUM CLOSED SUDDENLY. THE PATIENT AS WELL AS THE SURGEON WERE PROFOUNDLY ENDANGERED. AFFILIATE ALSO REPORTED THAT THE TEXTURE OF THE BLADES SEEMS TO BE DIFFERENT SINCE THE COLOR CHANGE TO GREY SOME TIME AGO. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED CHANGING IN THE MEDWATCH TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE BLADES WERE INSERTED INTO THE RETRACTOR BODY. WHEN OR-TEAM STARTED TO SPREAD (WITH A MINOR FORCE) ONE OF THE TWO BLADES BROKE TO PIECES, THE STERNUM CLOSED SUDDENLY. THE PATIENT AS WELL AS THE SURGEON WERE PROFOUNDLY ENDANGERED. AFFILIATE ALSO REPORTED THAT THE TEXTURE OF THE BLADES SEEMS TO BE DIFFERENT SINCE THE COLOR CHANGE TO GREY SOME TIME AGO. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED CHANGING IN THE MEDWATCH TO AN ADVERSE EVENT.

    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 Required Intervention