BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 IN ATS CYLINDRICAL CUFF, DUAL PORT/SINGL

    MDR report key: 2792325 · Received October 12, 2012

    Report

    Report Number
    1035617-2012-00008
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS DEVICE WAS MANUFACTURED ON 03/23/2012. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THERE WERE NO RELATED NON-CONFORMANCES. THE RETURNED DEVICE WAS OPENED AND THE CUFF EXAMINED. AS RECEIVED, THE CUFF WAS ROLLED INTO A VERY TIGHT MANNER (<3IN. DIAMETER). NORMAL ACCEPTANCE TESTING WAS PERFORMED. NO INDICATION OF DEFLATION/LEAKING/OR OTHER MALFUNCTION WAS OBSERVED. THE CUFF WAS EXAMINED FOR ANY PHYSICAL ABNORMALITIES. NONE WERE OBSERVED. THE CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED AS TESTING WAS UNABLE TO BE RE-CREATED. THERE IS NO SEGMENTATION IN THE CUFF, AS CLAIMED, OTHER THAN WHAT HAS POSSIBLY RESULTED FROM INCORRECT STORAGE AS MENTIONED IN THE INVESTIGATION AS THAT IS ONLY A PUCKERING OF MATERIAL WHILE IN ROLLED STATE. IN THE FLAT OR WHEN PROPERLY APPLIED, IT HAS A SMOOTH FLAT SURFACE PRESENTATION. POSSIBLE MIS-USE BY USER. INSTRUCTION FOR USE RECOMMENDS LIMB PROTECTION, APPLICATION OF CUFF IN A SMOOTH WRINKLE-FREE MANNER AND STORAGE OF THE CUFF ROLLED NO TIGHTER THAN A 5 INCH DIAMETER. NO INFORMATION WAS RECEIVED RELATIVE TO THESE RECOMMENDATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REUSABLE ZIMMER TOURNIQUET CUFF WAS USED ON UPPER EXTREMITY SURGERY. THE SURGEON WAS RESPONSIBLE FOR CHOOSING THE CUFF PRESSURE AT 250. POST SURGERY, THE TOURNIQUET CUFF WAS REMOVED AND THERE WERE RED LINES NOTED ON THE SKIN. THE SKIN APPARENTLY WAS INTACT. THE OPERATING ROOM MANAGER NOTED THAT THE CUFF HAD LUMPS AND WRINKLES THUS CAUSING IT TO BUCKLE. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT TWO CUFFS WERE PURCHASED EARLIER THIS YEAR AND THIS CUFF (1 OF 2) WAS FOUND TO HAVE A DIFFERENCE FROM THE OTHER (2 OF 2) IN THE FEEL OF THE CUFF MATERIAL. (THE SECOND OF THE TWO CUFFS WAS STATED TO BE WITHOUT ISSUE). IT WAS NOTED THAT SEGMENTATION WAS ALONG THE INSIDE OF THE CUFF, DESCRIBED BEST AS A ONE TO TWO INCH SMOOTH SPACE AND THEN AN APPROXIMATELY ¼ INCH WIDE RIDGE WAS FELT. THIS PATTERN WAS REPORTED TO HAVE REPEATED THROUGH THE LENGTH OF THE CUFF. THE RED LINES NOTED ON THE PATIENT¿S SKIN FOLLOWING REMOVAL OF THE CUFF AND CAST PADDING UNDERLAYMENT, MATCHED THE RIDGE LINES FELT IN THE CUFF. THERE WERE NO OPEN AREAS OF SKIN OR BRUISING SEEN AT ¿SAME DAY¿ DISCHARGE FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 18 IN ATS CYLINDRICAL CUFF, DUAL PORT/SINGL 18 IN ATS CYLINDRICAL CUFF, DUAL PORT/SINGL KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR