BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II DERMATOME WITH RATCHET

    MDR report key: 1882695 · Received October 13, 2010

    Report

    Report Number
    1526350-2010-00138
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER MESHGRAFT II WAS NOT MESHING CORRECTLY. ADD'L CLINICAL F/U RECEIVED ON (B)(6) 2010 INDICATED THAT THE MESHER WAS NOTED TO HAVE BENT TIPS ON THE SPIKES THAT MAKE THE CUTS THRU SKIN. HOSP STAFF WAS NOT SURE IF THIS WAS OBSERVED PRIOR TO PROCEDURE. THE GRAFT WAS NOT CUT THROUGH COMPLETELY ALL OVER. SOME OF THE AREA WAS OK, BUT OTHER AREAS SURGEON HAD TO USE KNIFE TO MAKE HOLES SINCE THE SPIKE BLADES DID NOT GO THRU THE SKIN. THE INITIAL GRAFT WAS USED, AND NO ADDITIONAL GRAFT WAS HARVESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESHGRAFT II DERMATOME WITH RATCHET MESHGRAFT II DERMATOME WITH RATCHET GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1