BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3289799 · Received August 8, 2013

    Report

    Report Number
    1526350-2013-00426
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, US AND CANADIAN 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 MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 10/09/1996 AND WAS LAST REPAIRED ON (B)(6) 1999 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE VERIFIED THE COMB TO BE DAMAGED. THE RIGHT END OF THE ROLLER WAS GNARLED AND GALLED AND THE GEAR WAS WARPED. THE LATCHING PINS WERE ALSO NOTICED TO BE TOO LOOSE AND WOULD NOT LOCK. PRIOR TO REPAIR, CALIBRATION AND SAMPLE GRAFT COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTENANCE 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 METAL GUARD IS BENT, AND DID NOT FUNCTION. NO ADD'L CLINICAL INFO WAS AVAILABLE REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375363 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1