BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8159398 · Received December 13, 2018

    Report

    Report Number
    0001526350-2018-01099
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 8, 2018
    Report Date
    January 24, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER: (B)(4). ON (B)(6) 2018, IT WAS REPORTED THAT DURING THE OPERATION THE DERMATOME STARTED TO TAKE TOO THICK OF SKIN GRAFT. THE FIRST GRAFT WAS OK, BUT THE SECOND ONE WAS PARTLY TOO THICK. THE DERMATOME TOOK A GRAFT SO DEEPLY THAT THE FAT ADIPOSE TISSUE CAME WITH IT. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, 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 AIR DERMATOME SERIAL NUMBER: (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE AIR DERMATOME BY MEDICREA ON DECEMBER 4, 2018 REVEALED THAT THE MOTOR WAS WORN AND CORRODED. THE THICKNESS CONTROL LEVER, RECIPROCATING ARM, AND THROTTLE LEVER WERE WORN. THE CONTROL BAR WAS OUT OF SPECIFICATION. THE CUSTOMER HOSE AND WIDTH PLATES WERE NOT RETURNED FOR EVALUATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY MEDICREA ON DECEMBER 7, 2018 WHICH INCLUDED REPLACEMENT OF THE BEARINGS, O-RINGS, SPRING SEAL, VESPEL BEARINGS, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SCREWS, MOTOR, MOTOR SLEEVE, CONTROL BAR, LEVER DIE CAST, BALL PLUNGER, RECIPROCATING ARM, AND ETCHED LEVER. AIR DERMATOME, 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 CONTROL BAR WAS OUT OF SPECIFICATION. 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 CONTROL BAR WAS OUT OF SPECIFICATION. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE OPERATION THE DERMATOME STARTED TO TAKE TOO THICK OF SKIN GRAFT. THE FIRST GRAFT WAS OK, BUT THE SECOND ONE WAS PARTLY TOO THICK. THE DERMATOME TOOK A GRAFT SO DEEPLY THAT THE FAT ADIPOSE TISSUE CAME WITH IT. THERE WAS A 15 MIN DELAY.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE - FOREIGN - (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE STARTED TO CUT TOO DEEP. HALF OF THE GRAFT WAS GOOD, AND THEN THE OTHER HALF TOO THICK. THEY TOOK ANOTHER GRAFT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002641 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 62682956

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention