BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3250004 · Received July 24, 2013

    Report

    Report Number
    1526350-2013-00394
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 25, 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 MAY 31, 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAT MESHER. 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 MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED ON 02/04/1992 AND WAS LAST REPAIRED ON 05/26/2012 FOR A NON-RELATED ISSUE. EVAL 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 EVAL. EVAL 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 WAS TEARING UP GRAFTS. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT THERE WERE ACTUALLY TWO EVENTS WITH THE DEVICE; HOWEVER, THE HOSPITAL STAFF WAS UNABLE TO PROVIDE DATES THAT EACH EVENT OCCURRED. IT WAS REPORTED THAT ONE EVENT OCCURRED WITH A TRAUMA SURGEON AND AN ADD'L GRAFT HAD TO BE HARVESTED AND SURGICAL TIME WAS EXTENDED. THE SECOND EVENT OCCURRED WITH A BURN SURGEON, HOWEVER, THE HOSPITAL STAFF WAS UNSURE IF THEY WERE ABLE TO SALVAGE THE GRAFT OR IF AN ADD'L GRAFT HARVEST WAS REQUIRED. THE SURGERY TIME WAS EXTENDED BY AN UNSPECIFIED AMOUNT OF TIME. THIS REPORT IS BEING SUBMITTED ALONG WITH MEDWATCH 1526350-2013-00349.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346077 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTER: 00-7703-020-00, SN# (B)(4)| CUTTER: 00-7703-030-00, SN# (B)(4)| CUTTER: 00-7703-040-00, SN# (B)(4)| CUTTER: 00-7703-015-00, SN# (B)(4)