BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2445581 · Received February 6, 2012

    Report

    Report Number
    1526350-2012-00022
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 12, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 20 YEARS OLD. THE LAST REPAIR WAS ON 03/15/2006, FOR AN UNK ISSUE. THE INSPECTION FOUND THAT THE DEVICE ARRIVED WITH A DAMAGED COMB. THE CAUSE OF THE REPORTED COMPLAINT WAS A DEVICE WITH SEVERAL DAMAGED COMPONENTS, DUE TO A LACK OF PREVENTATIVE MAINTENANCE. A REVIEW OF SALVAGED PARTS SHOWED DAMAGED COMPONENTS DUE TO EXCESSIVE WEAR AND TEAR. THE CALIBRATION COULD NOT BE CHECKED DUE TO THE DAMAGED COMB. THE CUTTER PRODUCED AN UNACCEPTABLE SAMPLE GRAFT. A DEVICE IN THIS CONDITION COULD EXHIBIT A NUMBER OF LESS THAN ACCEPTABLE RESULTS, INCLUDING THAT OF THE REPORTED COMPLAINT. THIS IS A RE-USABLE DEVICE, SUBJECT TO NORMAL WEAR AND TEAR, AND HAS NOT BEEN RETURNED TO ZIMMER FOR SERVICE OR PREVENTATIVE MAINTENANCE SINCE 03/2006. THE ZIMMER SKIN GRAFT MESHER SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS CATCHING AND TEARING THE GRAFT WHEN MOVING THROUGH THE MESHER. ADD'L CLINICAL F/U WITH THE HOSP INDICATED THAT THE SKIN STUCK AND RIPPED AS IT PASSED THROUGH THE DEVICE. IT WAS NOTED THAT THE POINTS ON THE TEETH WERE CROOKED OR BENT. THE INITIAL GRAFT WAS RUINED AND AN ADD'L DONOR SITE WAS HARVESTED AND MESHED WITH AN ALTERNATE, AVAILABLE ON-SITE, DEVICE. THE PROCESS FOR OBTAINING THE ADD'L DONOR SITE HARVEST AND ALTERNATE DEVICE WAS ESTIMATED TO HAVE INCREASED THE SURGICAL TIME BY APPROX 10-15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1