BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8059833 · Received November 12, 2018

    Report

    Report Number
    0001526350-2018-00504
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ON AUGUST 9, 2017, IT WAS REPORTED THAT DURING THE PRODUCT REVIEW BY MEDICREA IT WAS FOUND THAT THE COMB WAS BADLY BENT. ALSO, THE TWO CUTTERS WERE WORN AND MUST BE REPLACED PRIOR TO USE BY THE CUSTOMER. THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (B)(4), 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. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED SKIN GRAFT MESHER SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE (B)(6) SERVICE PORTAL. PRODUCT REVIEW OF THE SKIN GRAFT MESHER BY MEDICREA ON (B)(6) 2017 REVEALED THAT THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND THE 3:1 RATIO CUTTER, SERIAL NUMBER (B)(4), WERE BOTH WORN AND DID NOT PRODUCE PASSING SAMPLE MESHES. THE COMB WAS BADLY BENT AND THE BOTTOM ROLLER, GEAR, BEARING AND SHOULDER BOLT WERE ALL WORN. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY MEDICREA ON (B)(6) 2017 WHICH INCLUDED REPLACEMENT OF THE COMB, BOTTOM ROLL, ROLLER GEAR, BEARING WASHER AND SHOULDER BOLT. SKIN GRAFT MESHER, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED PER (B)(6). THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE COMB WAS BADLY BENT. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND THE 3:1 RATIO CUTTER, SERIAL NUMBER (B)(4), WERE BOTH WORN AND DID NOT PRODUCE PASSING SAMPLE MESHES. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE COMB WAS BADLY BENT. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND THE 3:1 RATIO CUTTER, SERIAL NUMBER (B)(4), WERE BOTH WORN AND DID NOT PRODUCE PASSING SAMPLE MESHES. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BENT COMB AND IS DAMAGED PRODUCT . ALSO MENTIONED THAT PRODUCT RECEIVED WITH 2 CUTTERS CUTTER 1,5 AND CUTTER 3 THESE 2 CUTTERS ARE WEAR AND MUST BE REPLACED BEFORE USE BY THE CUSTOMER. CONSTATATION THE COMB IS BADLY BENT THE....

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900109 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 33101400

    Patients

    Seq Age Sex Outcome Treatment
    1