BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3943569 · Received April 30, 2014

    Report

    Report Number
    1526350-2014-00341
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 03/16/2009 AND WAS LAST REPAIRED ON 10/30/2013 FOR A NON-RELATED ISSUE. PREVIOUS REPAIR INCLUDED REPLACEMENT OF THE RATCHET GEAR, SLIDING PIN, AND SPRING. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE COMB AND LEFT SIDE PLATE, AS WELL AS WEAR TO THE ROLLER GEAR TEETH. THE CUSTOMER DID NOT RETURN A RATCHET OR ANY CUTTERS FOR EVALUATION. AS A RESULT, THE CUSTOMER'S REPORTED EVENT OF THE DEVICE CRANKING BACKWARDS AND NOT FEEDING COULD NOT BE CONFIRMED. A CAUSE OF THE CUSTOMER'S REPORTED EVENT COULD NOT BE DETERMINED AS IT WAS NOT REPRODUCED DURING TESTING; HOWEVER, THE DAMAGED COMB AND/OR POTENTIALLY DAMAGED CUTTERS COULD PREVENT SKIN FROM PROPERLY FEEDING THROUGH THE ZIMMER SKIN GRAFT MESHER. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT, THE ZIMMER SKIN GRAFT MESHER CRANKED BACKWARDS AND IT DID NOT FEED. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258554 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1