BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3213369 · Received July 3, 2013

    Report

    Report Number
    1526350-2013-00349
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(4) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAFT MESHER. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURE FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 02/04/1992 AND WAS LAST REPAIRED ON (B)(6) 2012 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE COMB AND GEAR WERE DAMAGED. A TEST MESH AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. FOUR CUTTERS WERE ALSO RETURNED FOR EVALUATION. EVALUATION OF THE CUTTERS DETERMINED THAT THE 1.5:1 CUTTER PRODUCED AN ACCEPTABLE TEST MESHES AND THE 2:1, 3:1 AND 4;1 CUTTERS PRODUCED UNACCEPTABLE TEST MESHES. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING. ACCORDING TO THE INSTRUCTIONS FOR USE 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 TORE THE SKIN GRAFTS. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT AN ADDITIONAL GRAFT WAS REQUIRED TO BE HARVESTED AND SURGERY TIME WAS EXTENDED BY AN UNSPECIFIED AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303465 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00-7703-040-00, SN# (B)(4)| 00-7703-020-00, SN# (B)(4)| CUTTERS: 00-7703-015-00, SN# (B)(4)