BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 6464712 · Received April 6, 2017

    Report

    Report Number
    0001526350-2017-00175
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    June 28, 2016
    Report Date
    April 6, 2017
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1.5:1 RATIO CUTTER, SERIAL NUMBER 1211040, A 2:1 RATIO CUTTER, SERIAL NUMBER 1307004, A 3:1 RATIO CUTTER, SERIAL NUMBER 1407109, AND A 4:1 RATIO CUTTER, SERIAL NUMBER 1212049, FOR EVALUATION. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED THE SKIN GRAFT MESHER THREE TIMES. THE LAST REPAIR WAS (B)(6) 2015 WHERE IT WAS REPORTED THAT THE DEVICE HAD A BENT COMB AND THE DAMAGED COMB WAS REPLACED. THIS IS NOT A RELATED ISSUE. THE SKIN GRAFT MESHER WAS MANUFACTURED ON NOVEMBER 26, 2008, AND IS OVER 7 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 REVEALED NICKS AND SCRATCHES TO THE MESHER HANDLE. THE LATCHING PINS ENGAGE AS INTENDED. THE COMB WAS BENT ON THE RIGHT HAND SIDE AND WAS SLIGHTLY DEFORMED. THE ROLLER GEAR WAS WORN AND THE ROLLER SHAFT EXTENSION WAS SLIGHTLY GALLED. THE 1.5:1 RATIO CUTTER HAD WEAR TO THE ROLLER GEAR AND BLADES. THE 2:1 RATIO CUTTER HAD WEAR TO THE ROLLER GEAR AND BLADES. THE 3:1 RATIO CUTTER HAD SLIGHT WEAR TO THE ROLLER GEAR AND BLADES. THE 4:1 RATIO CUTTER HAD WEAR TO THE ROLLER GEAR AND THE BLADES HAD SOME NICKS AND WERE WORN. THE TEST MESH USING THE CUSTOMER'S MESHER WAS UNABLE TO BE PERFORMED DUE TO THE NATURE OF THE COMB. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY ZIMMER BIOMET SURGICAL WHICH INCLUDED REPLACEMENT OF THE DAMAGED SIDE PLATES, ROLLER AND COMB. THE 1.5:1 RATIO CUTTER WAS TESTED AND FAILED TO PRODUCE A COMPLETE CUT. THE 2:1 RATIO CUTTER PRODUCED A COMPLETE CUT. THE 3:1 RATIO CUTTER PRODUCED A COMPLETE CUT. THE 4:1 RATIO CUTTER PRODUCED A COMPLETE CUT. 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 COMB WAS BENT ON THE RIGHT HAND SIDE AND WAS SLIGHTLY DEFORMED. BASED ON THE INFORMATION THAT WAS PROVIDED THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED. HOWEVER, DURING THE INITIAL INSPECTION IT WAS NOTED THAT THE COMB WAS BENT ON THE RIGHT HAND SIDE AND WAS SLIGHTLY DEFORMED. THE IFU STATES THAT ¿TO AVOID DAMAGE TO THE COMB, THE COMB MUST BE IN THE HORIZONTAL POSITION BEFORE THE CUTTER IS INSTALLED.¿ THE SKIN GRAFT MESHER WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A BENT COMB. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246722 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 61137431

    Patients

    Seq Age Sex Outcome Treatment
    1