BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3810801 · Received March 21, 2014

    Report

    Report Number
    1526350-2014-00215
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 08/31/2010 AND WAS LAST REPAIRED ON 08/06/2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THE COMB HAD NUMEROUS BENT TINES ON THE LEFT SIDE AND THE ROLLER HAD MINOR GNARLING OF THE RIGHT END OF THE ROLLER GEAR TEETH WERE EXCESSIVELY GALLED WITH A TOOTH MISSING AND THE GEAR SLIGHTLY DEFORMED. IT WAS ALSO NOTED THAT BOTH CUTTER GEARS WERE GALLED. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. BOTH CUTTERS PASSED CUTTER EVALUATION. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE GEARS AND BUSHING TO BOTH CUTTERS, ROLLER AND ROLLER GEAR, COMB, CARRIER GUIDE, BOTH SIDE PLATES AND HINGE TOPS, RATCHET SPRING, RATCHET GEAR AND SLIDING PIN. IMPROPER HANDLING MOST LIKELY CAUSED THE DAMAGE TO THE ROLLER AND CUTTER GEARS AND THE COMB, WHICH MOST LIKELY CAUSED THE CUSTOMER'S EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DERMACARRIER BECAME STUCK IN THE MESHER AND THE PINS COULD NOT BE OPENED, IN THE ZIMMER SKIN GRAFT MESHER. IT WAS OPENED VIA REMOVING THE HINGE BOLTS AND FORCING THE CUTTER OUT. IT WAS NOTED THAT THE GEARS NEED TO BE REPLACED. THE FACILITY REPORTING THE EVENT IS A CADAVER TISSUE BANK. AS SUCH, THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169833 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER SKIN GRAFT MESHER CUTTER 2:1 RATIO 1108025| ZIMMER SKIN GRAFT MESHER CUTTER 1.5:1 RATIO1204021