BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMACARRIER II 9:1 STERILE

    MDR report key: 8726985 · Received June 24, 2019

    Report

    Report Number
    0001526350-2019-00503
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 28, 2019
    Report Date
    October 10, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. UDI#: (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE DERMACARRIER II 9:1 STERILE, PART NUMBER 00219501500, WILL NOT BE REVIEWED AS A LIMITED INVESTIGATION IS BEING PERFORMED FOR THIS COMPLAINT. THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA AND COMPLAINTS ARE MONITORED THROUGH MONTHLY MEETINGS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. THE COMPLAINT HISTORY FOR THE DERMACARRIER II 9:1 STERILE, PART NUMBER 00219501500, WILL NOT BE REVIEWED AS A LIMITED INVESTIGATION IS BEING PERFORMED FOR THIS COMPLAINT. THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA AND COMPLAINTS ARE MONITORED THROUGH MONTHLY MEETINGS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. ON (B)(6) 2019, IT WAS REPORTED FROM (B)(6) - SGL 21 THAT A DERMACARRIER II 9:1 STERILE MESHED AN EXPANSION RATIO OF 15:1. ON 04 OCT 2019, A RETURNED PRODUCT INVESTIGATION WAS PERFORMED ON THE DERMACARRIER II 9:1 STERILE. THE PHYSICAL EVALUATION REVEALED THAT THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED AND THERE WERE NO OTHER ISSUES FOUND WITH THE DEVICE. THE DERMACARRIER WAS THE CORRECT RATIO. ALSO, 9:1 IS THE LARGEST RATIO DERMACARRIER MADE AT ZIMMER BIOMET. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED AND THERE WERE NO OTHER ISSUES FOUND WITH THE DEVICE. 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 · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. IT WAS REPORTED THAT THERE WAS A SERIOUS INJURY, BUT THE INJURY WAS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PLATE USED HAS MESHED THE SKIN GRAFT IN A 15:1 INSTEAD OF 9:1 WHICH WOULD RESULT IN BAD GRAFTING AND A POTENTIALLY UNSIGHTLY GRAFT. THE EVENT TOOK PLACE DURING SURGERY, AND IT WAS REPORTED THAT THERE WAS AN INJURY, BUT DETAILS WERE NOT PROVIDED, AND THERE WAS A DELAY OF 10 MINUTES. AN ALTERNATE PLATE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521678 DERMACARRIER II 9:1 STERILE SKIN GRAFT CARRIER FZW ZIMMER SURGICAL, INC. 63372115

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other