BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER COMPLETE

    MDR report key: 3697919 · Received January 8, 2014

    Report

    Report Number
    1526350-2014-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 9, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER SKIN GRAFT MESHER. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 07/24/1995 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE VERIFIED THE COMB TO BE DEFORMED. ADDITIONALLY, GNARLING OF THE RIGHT END OF THE ROLLER AND DEFORMATION OF THE UPPER GEAR GUARD WAS OBSERVED. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE PERFORMED DUE TO THE DAMAGES COMB. CUSTOMER RETURNED A 1.5:1 RATIO CUTTER SERIAL NUMBER (B)(4), WHICH DISPLAYED MINOR NICKS. THE CUTTER FAILED CUTTER EVALUATION AND WAS RETURNED TO THE CUSTOMER AS NON-REPAIRABLE. THE DEVICE HAS NO REPAIR HISTORY AT ZIMMER SURGICAL SINCE BEING MANUFACTURED 19 YEARS AGO. LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED THE DAMAGE TO THE COMB, ROLLER, UPPER GEAR GUARD AND CUTTER. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER HAD A PIECE BENT, AND THE CUTTER BAR WAS BROKEN. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE BENT PIECE WAS NOTED DURING CLEANING OF THE DEVICE WAND THERE WAS NO PATIENT INVOLVEMENT OR IMPACT TO A SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14763 ZIMMER SKIN GRAFT MESHER COMPLETE ZIMMER SKIN GRAFT MESHER COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER SKIN GRAFT MESHER CUTTER