BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8916375 · Received August 21, 2019

    Report

    Report Number
    0001526350-2019-00669
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 29, 2019
    Report Date
    November 13, 2019
    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
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD FOR ZIMMER SKIN GRAFT MESHER SERIAL NUMBER 04334 WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH THE DEVICE. THE RECORD REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE EVALUATION AND REPAIR. THE CUSTOMER RETURNED A ZIMMER SKIN GRAFT MESHER SERIAL NUMBER (B)(4) AS WELL AS 1.5:1 CUTTER SERIAL NUMBER (B)(4) , 2:1 CUTTER SERIAL NUMBER 1201042, 3:1 CUTTER SERIAL NUMBER (B)(4), AND 4:1 CUTTER SERIAL NUMBER (B)(4) FOR EVALUATION. EVALUATION OF THE DEVICE ON 1 AUGUST 2019 NOTED THAT PRETESTS ON THE MESHER COULD NOT BE PERFORMED DUE TO THE DAMAGED COMB AND THAT THE BOTTOM ROLLER AND ROLLER GEAR WERE WORN. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE SIDE PLATES WERE WORN ON THE INSIDE EDGE AND THAT THE SHOULDER BOLTS, WASHERS, AND NUTS NEEDED TO BE REPLACED. ALL FOUR OF THE RETURNED CUTTERS WERE EVALUATED AND NOTED TO HAVE NOT PRODUCED A PASSING TEST MESH. REPAIR OF THE MESHER OCCURRED ON 13 AUGUST 2019 AND INVOLVED REPLACING THE COMB, BOTTOM ROLLER, ROLLER GEAR, SIDE PLATES, THE SHOULDER BOLTS, WASHERS, AND NUTS. THE TECHNICIAN THEN RECALIBRATED THE DEVICE AND VERIFIED THAT IT WAS FUNCTIONING AS INTENDED. THE MESHER AND ITS CUTTERS WERE THEN RETURNED TO THE CUSTOMER WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. WHILE THE SERVICE TECHNICIAN CONFIRMED THAT THE COMB WAS DAMAGED, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE COMB TO BECOME DAMAGED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THAT THERE ARE NO FURTHER ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO OF THE PRONGS ON THE GRATE OF DEVICE WERE BENT ON THE SIDE. THE ISSUE OCCURRED DURING DECONTAMINATION OR STERILE PROCESSING THEREFORE, THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709448 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 61734304

    Patients

    Seq Age Sex Outcome Treatment
    1 PART NO. 00770301500.SERIAL NO. (B)(4).| PART NO. 00770302000.SERIAL NO. (B)(4).| PART NO. 00770303000. SERIAL NO. (B)(4).| PART NO. 00770304000.SERIAL NO. (B)(4).