BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II COMPLETE

    MDR report key: 7923157 · Received October 1, 2018

    Report

    Report Number
    0001526350-2018-00910
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Report Date
    October 31, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PPREAMEND
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ON SEPTEMBER 14, 2018, IT WAS REPORTED THAT THE METALLIC STEM DOES NOT CATCH THE ROLLS. THE CUSTOMER RETURNED A MESHGRAFT II DEVICE, 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. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED MESHGRAFT II SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. PRODUCT REVIEW OF THE MESHGRAFT II BY MEDICREA ON OCTOBER 4, 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS. THE DEVICE WAS DAMAGED AND THERE WERE PARTS FROM THE OLDER VERSION OF THE DEVICE. IT WAS NOTED THAT THE CUTTER KIT , ROLLER SIDE PLATE, HANDLE, GEAR AND SCREW WERE DAMAGED. REPAIR OF THE MESHGRAFT II WAS PERFORMED BY MEDICREA ON OCTOBER 4, 2018 WHICH INCLUDED REPLACEMENT OF THE CUTTER, SIDE PLATES, ROLLER, HANDLE, RATCHET GEAR, AND SET SCREW. MESHGRAFT II, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE CUTTER KIT , ROLLER SIDE PLATE, HANDLE, GEAR AND SCREW WERE DAMAGED. 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 ROLLER SIDE PLATE, HANDLE, GEAR AND SCREW WERE DAMAGED. 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 · 0

    NO ADDITIONAL EVENT INFORMATION WAS RECEIVED.

    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.

    Description of Event or Problem · 1

    THE METALLIC STEM DOES NOT CATCH THE ROLLS. EVENT OCCURRED DURING SURGERY AND THERE WAS A DELAY OF 1-2 HOURS WHEN THE PATIENT WAS UNDER ANESTHESIA. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764561 MESHGRAFT II COMPLETE EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1