BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3130228 · Received May 22, 2013

    Report

    Report Number
    1526350-2013-00261
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    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 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 MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 02/02/1996 AND WAS LAST REPAIRED ON 07/02/2010. EVALUATION OF THE DEVICE OBSERVED THAT THE COMB WAS BENT. IT WAS ALSO OBSERVED THAT THE GEAR GUARD WAS BENT AND THE ROLLER, ROLLER GEAR, SIDE PLATES AND RATCHET GEAR WERE DAMAGED. A TEST MESH AND CALIBRATION COULD NOT BE PERFORMED DUE TO DAMAGE OF THE COMB. ONE CUTTER, 1.5:1 RATIO CUTTER SERIAL NUMBER (B)(4), WAS RETURNED FOR EVALUATION. EVALUATION OF THE CUTTER DETERMINED THAT THE CUTTER PRODUCED AN UNACCEPTABLE TEST MESH. 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 HAD A BENT COMB. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE DEVICE WAS NOT IN PATIENT USE WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT INJURY, INCREASED SURGICAL TIME OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227163 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER SKIN GRAFT CUTTER 00-7703-015-00,| SN# (B)(4)