BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II INSTRUMENT ONLY

    MDR report key: 7811072 · Received August 23, 2018

    Report

    Report Number
    0001526350-2018-00823
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PPREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON (B)(6) 2018, IT WAS REPORTED THAT THE GRAFTING DOES NOT PASS BECAUSE IT IS VERY TIGHT. 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 VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE MESHGRAFT II BY MEDICREA ON AUGUST 7, 2018 REVEALED THAT THE INCOMING TEST FAILED. THE CUTTER, ROLLER AND SIDE PLATE WERE DEFECTIVE AND OLD. REPAIR OF THE MESHGRAFT II HAS NOT YET BEEN PERFORMED BY MEDICREA AS THE QUOTE FOR SERVICE IS STILL PENDING CUSTOMER APPROVAL. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE INCOMING TEST FAILED. THE CUTTER, ROLLER AND SIDE PLATE WERE DEFECTIVE AND OLD. 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 INCOMING TEST FAILED. THE CUTTER, ROLLER AND SIDE PLATE WERE DEFECTIVE AND OLD. 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

    THE GRAFTING DOES NOT PASS BECAUSE IT IS VERY TIGHT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. INVESTIGATION REVEALED THAT THE INCOMING TEST FAILED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651947 MESHGRAFT II INSTRUMENT ONLY EXPANDER, SKIN GRAFT, SURGICAL FZW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1