BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3810811 · Received March 21, 2014

    Report

    Report Number
    1526350-2014-00216
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 19, 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

    ON (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 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 02/07/1995 AND WAS LAST REPAIRED ON 1/05/2011 FOR A SIMILAR ISSUE. EVALUATION REVEALED THAT THE COMB HAD BENT TINES ON BOTH SIDES. EVALUATION OF THE DEVICE OBSERVED THAT HE COMB HAD BENT TINES ON BOTH SIDES AND DAMAGE TO THE ROLLER AND ROLLER GEAR. PRIOR TO REPAIR, A TEST MESH COULD NOT BE PERFORMED DUE TO DAMAGED COMB. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMB, ROLLER AND ROLLER GEAR, BOTH SIDE PLATES AND BUSHINGS. LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE DAMAGE TO THE COMB. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER EQUIPMENT WAS DAMAGED. THE REPORTED ISSUE OCCURRED BEFORE SURGERY, THE COMB ON THE DEVICE WAS NOTICED TO BE BENT DURING SET UP FOR THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT INJURY ASSOCIATED WITH THE REPORT AND AN ALTERNATE DEVICE WAS RETRIEVED FOR USE DURING THE SURGERY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169143 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1