BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 6449264 · Received March 31, 2017

    Report

    Report Number
    0001526350-2017-00146
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Report Date
    March 30, 2017
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND A 3:1 RATIO CUTTER, SERIAL NUMBER (B)(4), FOR EVALUATION. ZIMMER AUSTRALIA HAS PREVIOUSLY REPAIRED/EVALUATED THE SKIN GRAFT MESHER THREE TIMES AS DOCUMENTED IN SYSTEMS, APPLICATIONS, AND PRODUCTS IN DATA PROCESSING (SAP). THE LAST REPAIR WAS AUGUST 18, 2015 WHERE IT WAS REPORTED THAT THE DEVICE WAS DUE IN FOR SERVICE AND THE GEAR PACK WAS REPLACED. THIS IS NOT A RELATED ISSUE. THE SKIN GRAFT MESHER WAS MANUFACTURED ON APRIL 25, 1997, AND IS OVER 19 YEARS OLD AT THE TIME THIS COMPLAINT WAS GENERATED. THE PREVIOUS REPAIR REPORT WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. INITIAL QA INSPECTION OF THE SKIN GRAFT MESHER BY ZIMMER (B)(4) ON MAY 9, 2016 REVEALED THAT THE PRE-TEST CUT COULD NOT BE PERFORMED DUE TO THE COMB BEING OUT OF SHAPE AND NOT ABLE TO ROLL SMOOTHLY. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND THE 3:1 RATIO CUTTER, SERIAL NUMBER (B)(4) , BOTH MET ZIMMER BIOMET MESH TEST REQUIREMENTS. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY ZIMMER (B)(4) ON MAY 9, 2016 WHICH INCLUDED REPLACEMENT OF THE ZIMMER SKIN GRAFT MESHER COMB PACK. THE SKIN GRAFT MESHER WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE INITIAL INSPECTION IT WAS NOTED THAT THE DEVICE HAD A DAMAGED COMB. BASED ON THE INFORMATION THAT WAS PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED. THE IFU PROVIDES GUIDANCE ON HOW TO PROPERLY INSTALL AND REMOVE THE CUTTER AS TO NOT DAMAGE THE COMB. ¿HOLDING THE CUTTER ON BOTH ENDS, PLACE CUTTER (E) HORIZONTALLY ON TOP OF THE COMB WITH THE DRIVE GEARS ALIGNED. ASSURE THE CUTTER DROPS INTO PLACE BY PRESSING DOWN ON THE COMB ONCE OR TWICE. ASSURE THE CUTTER REMAINS HORIZONTAL DURING INSTALLATION.¿ AND ¿TO REMOVE THE CUTTER, HOLD ON BOTH ENDS AND LIFT OUT OF MESHER. ASSURE THE CUTTER REMAINS HORIZONTAL DURING DISASSEMBLY.¿ THE SKIN GRAFT MESHER WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PROBLEM WITH THE DEVICE. INITIAL INSPECTION OF THE RETURNED MESHER REVEALED THE COMB WAS OUT OF SHAPE. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231376 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 31387100

    Patients

    Seq Age Sex Outcome Treatment
    1