BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER COMPLETE

    MDR report key: 3874621 · Received April 24, 2014

    Report

    Report Number
    1526350-2014-00322
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 31, 2012, US AND (B)(4) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR DEVICE INFORMING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 03/03/2005 AND WAS LAST REPAIRED ON 12/15/2005 FOR AN UNKNOWN ISSUE. EVALUATION OF THE DEVICE OBSERVED THE COMB HAD SLIGHTLY BENT TINES ON THE RIGHT END. THE ROLLER HAD WORN GEAR TEETH AND THE RIGHT END WAS GNARLED. THE CUSTOMER RETURNED A CUTTER FOR EVALUATION IT HAD DAMAGE ALONG THE BLADES AND WEAR TO THE GEAR TEETH. THE SIDE PLATES WERE GOUGED AT THE ENTRY OF THE ROLLER AD AT THE EARS. THE CUSTOMER DID NOT RETURN A RATCHET FOR EVALUATION. PRIOR TO REPAIR, BOTH THE TEST MESH AND THE CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB. THE CUTTER DID NOT PASS CUTTER EVALUATION AND WAS RETURNED TO THE CUSTOMER AS NON-REPAIRABLE. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMB, ROLLER AND ROLLER GEAR, SIDE PLATES, BALL DETENTS, WASHERS AND SHOULDER BOLTS. THE DEVICE IS NINE YEARS OLD AND HAS NOT BEEN RETURNED FOR SERVICE AT ZIMMER SURGICAL IN OVER RIGHT YEARS; THEREFORE, LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING BY THE CUSTOMER MOST LIKELY CAUSED THE DAMAGE TO THE COMB OF THE DEVICE, WHICH LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER COMPLETE WAS NOT MESHING CORRECTLY. 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
    248176 ZIMMER SKIN GRAFT MESHER COMPLETE ZIMMER SKIN GRAFT MESHER COMPLETE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1