BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER COMPLETE

    MDR report key: 3831814 · Received March 6, 2014

    Report

    Report Number
    1526350-2014-00154
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 7, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MAY 31, 2012, US AND CANADIAN 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 01/19/2011 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THAT THE RATCHET DID NOT FUNCTION. THERE WERE NUMEROUS TINES BENT AND FLATTENED ON THE COMB. THE INVESTIGATION ALSO EXPOSED GALLING TO THE RIGHT END OF THE ROLLER. WHILE INSPECTING THE OVERALL DEVICE, WORN SHOULDER BOLTS AND SIDE PLATES WERE SEEN. IT WAS ALSO OBSERVED THAT THE COMB WAS DAMAGED AND THAT LATCHING PINS WERE WORN. PRIOR TO REPAIR, A TEST MESH AND CALIBRATION CHECK COULD NOT BE OBTAINED AS A RESULT OF THE DAMAGED COMB. THE CUSTOMER RETURNED FOUR CUTTERS. THE 2:1, 3:1 AND 4:1 RATIO CUTTERS HAD MINOR NICKS. CUTTER OF 1.5:1 RATIO DISPLAYED EXCESSIVE WEAR AND MISSING AND DAMAGED BLADES. THE 1.5:1 AND 4:1 RATIO CUTTERS FAILED CUTTER EVALUATION AND WERE RETURNED TO THE CUSTOMER AS NON-REPAIRABLE; THE 2:1 AND 3:1 RATIO CUTTERS PASSED CUTTER EVALUATION AND WERE RETURNED TO THE CUSTOMER. CUSTOMER DID NOT RETURN CUTTERS OR CARRIERS FOR EVALUATION. IMPROPER HANDLING MOST LIKELY CAUSED THE DAMAGE TO THE COMB, WHICH MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. ADDITIONALLY, IMPROPER HANDLING MOST LIKELY CAUSE THE DAMAGE TO THE LATCHING PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS NOT WORKING PROPERLY BECAUSE OF A RATCHET ISSUE. 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
    134970 ZIMMER SKIN GRAFT MESHER COMPLETE ZIMMER SKIN GRAFT MESHER COMPLETE FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1