BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2427527 · Received January 4, 2012

    Report

    Report Number
    1526350-2012-00002
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 8, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH TWO RATCHETS. ONE RATCHET WOULD NOT OPERATE. THE OTHER RATCHET OPERATED CORRECTLY. THE DEVICE WAS TESTED WITH A SAMPLE CUTTER, AS NO CUTTER WAS RETURNED WITH THE DEVICE. THE TEST CUT WAS ACCEPTABLE. IT WAS DETERMINED THAT RATCHET GEAR SET SCREW WAS INCORRECTLY ADJUSTED, STOPPING THE RATCHET GEAR FROM MOVING. VISUAL EXAMINATION OF THE DEVICE NOTED THAT THE SIDE PLATES, GEAR AND ROLLER WERE WORN. 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 NOT WORKING PROPERLY. ADD'L CLINICAL F/U WITH THE HOSPITAL INDICATED THAT THE HANDLE DID NOT RATCHET, AND RESULTED IN A PORTION OF THE GRAFT BEING SHREDDED. THE PLANNED PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF HARM, INJURY, ADD'L DONOR SITE HARVEST, ADD'L SURGICAL INTERVENTION, ALTERNATE DEVICE USE, OR INCREASED SURGICAL TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1