BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3573404 · Received November 1, 2013

    Report

    Report Number
    1526350-2013-00641
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    May 1, 2013
    Report Date
    October 4, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 03/21/1994 AND WAS LAST REPAIRED ON 08/08/2007 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE RATCHET GEAR DID NOT FUNCTION NORMALLY. THE RIGHT SIDE OF THE COMB WAS DAMAGED AND THE LEFT ROLLER BUSHING WAS EXPOSED. IT WAS ALSO OBSERVED THAT THE RIGHT END OF THE ROLLER WAS GNARLED AND THE SIDE PLATES OF THE DEVICE WERE DAMAGED. PRIOR TO REPAIR, THE DEVICE PRODUCED AN UNACCEPTABLE TEST MESH AND WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT AND RIGHT SIDE. LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING WAS MOST LIKELY THE CAUSE FOR THE LACK OF CALIBRATION AND DAMAGE TO THE COMB, RATCHET AND ROLLER. THE LACK OF CALIBRATION AND DAMAGE TO THE COMB, RATCHET GEAR AND ROLLER MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. ADDITIONALLY, LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING WAS MOST LIKELY THE CAUSE FOR THE DAMAGE TO THE SIDE PLATES AND EXPOSED ROLLER BUSHING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS NOT FUNCTIONING PROPERLY. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT. HOWEVER, DURING DEVICE ANALYSIS, IT WAS DETERMINED THAT THE COMB WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564812 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1