BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 7182977 · Received January 11, 2018

    Report

    Report Number
    0001526350-2018-00034
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Report Date
    January 11, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4) . ON (B)(6) 2016, IT WAS REPORTED THAT THE MESHER CRADLE WAS BENT. THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1:1 RATIO CUTTER, SERIAL NUMBER 1201087, A 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), A 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND A 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE DHR ASSOCIATED WITH THIS SERIALIZED DEVICE WAS UNAVAILABLE FOR REVIEW AT THE TIME OF PROCESSING THIS COMPLAINT. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED SKIN GRAFT MESHER SERIAL NUMBER (B)(4) TWO TIMES AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(4) 2011 WHERE IT WAS REPORTED THAT THE DEVICE WILL NOT FEED AND THE ROLLER, WORN BUSHINGS, WORN SIDE PLATES, DAMAGED COMB, AND GEARS WERE REPLACED. THIS IS NOT A RELATED ISSUE. THE DEVICE HISTORY RECORD (DHR) FOR THE 1.5 CUTTER NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ZIMMER BIOMET SURGICAL HAS NOT PREVIOUSLY REPAIRED/EVALUATED 1.5 CUTTER SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. INITIAL QA INSPECTION OF THE SKIN GRAFT MESHER ON (B)(6) 2016 REVEALED MINOR COSMETIC DAMAGE TO THE MESHER HANDLE INCLUDING NICKS AND SCRATCHES. THE LATCHING PINS ENGAGE AS INTENDED. THE HINGES WERE VERY TIGHT. THE COMB WAS SLIGHTLY BENT ON THE LEFT HAND AND RIGHT HAND SIDES. THERE WAS SIGNIFICANT WEAR NOTED TO THE ROLLER GEAR AND SLIGHT GALLING TO THE ROLLER SHAFT EXTENSION. THE ROLLER SHAFT EXTENSION END WAS DEFORMED. THE RATCHET GEAR WAS INSERTED INTO THE RATCHET HANDLE BACKWARDS AND COULD EASILY BE POPPED OUT OF THE ASSEMBLY. THE 1:1 RATIO CUTTER, SERIAL NUMBER (B)(4) , HAD SLIGHT WEAR TO THE CUTTER BLADES. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER 1406004, HAD SLIGHT WEAR TO THE CUTTER BLADES. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), HAD SOME NICKS TO THE CUTTER BLADES. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), HAD NICKS TO THE CUTTER BLADES THROUGHOUT. THE TEST MESH USING THE CUSTOMER¿S MESHER AND RATCHET WAS UNABLE TO BE PERFORMED DUE TO THE BENT COMB. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON NOVEMBER 1, 2016 WHICH INCLUDED REPLACEMENT OF THE DAMAGED SIDE PLATES, BUSHINGS, ROLLER, COMB, GEAR AND CARRIER GUIDE. THE 1:1 RATIO CUTTER, SERIAL NUMBER (B)(4), PRODUCED A PASSING CUT. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), PRODUCED AN INCOMPLETE CUT AND WAS DEEMED NON-REPAIRABLE. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), PRODUCED A PASSING CUT. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), PRODUCED A PASSING CUT. SKIN GRAFT MESHER, SERIAL NUMBER 00102, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING INITIAL INSPECTION THE COMB WAS SLIGHTLY BENT. THE ROOT CAUSE OF THE BENT CRADLE CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION. THE ISSUE WAS RESOLVED WITH THE REPLACED DAMAGED SIDE PLATES, BUSHINGS, ROLLER, COMB, GEAR AND CARRIER GUIDE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. SKIN GRAFT MESHER, SERIAL NUMBER (B)(4), WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. NO FURTHER CONCLUSIONS CAN BE DRAWN FROM THE COMPLAINT HISTORY REVIEW THAT WARRANTS FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MESHER CRADLE WAS BENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. INVESTIGATION REVEALED THAT THE COMB WAS SLIGHTLY BENT ON THE LEFT HAND AND RIGHT HAND SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25995 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 2257600

    Patients

    Seq Age Sex Outcome Treatment
    1