BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7007909 · Received November 7, 2017

    Report

    Report Number
    0001526350-2017-00826
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    November 3, 2017
    Report Date
    December 16, 2017
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. ON (B)(6) 2017, IT WAS REPORTED THAT THE AIR DERMATOME TOOK AN INCONSISTENT GRAFT BOTH VERTICALLY AND HORIZONTALLY THROUGHOUT THE GRAFT. PER THE STAFF THE DERMATOME AUDIBLY SOUNDED OKAY, BUT ENDED UP CUTTING A VERY POOR GRAFT. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER 112748, FOR EVALUATION. THE CUSTOMER ALSO RETURNED A HOSE AND 1¿/2¿/3¿/4¿ WIDTH PLATES, FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR AND PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) TWO TIMES AS DOCUMENTED IN THE REPAIR REPORTS IN (B)(6). THE LAST REPAIR WAS (B)(6) 2017 WHERE THE DEVICE WAS RETURNED AFTER BEING USED AS A LOANER UNIT AND THE BEARINGS WERE REPLACED. INITIAL QA INSPECTION OF THE AIR DERMATOME ON (B)(6) 2017 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATION AT THE 0 SETTING ONLY. THE MOTOR SPEED WAS WITHIN SPECIFICATIONS AND THE CONTROL BAR WAS IN THE CORRECT POSITION. THE AIR DERMATOME WAS RECALIBRATED TO CORRECT THE CALIBRATION BEING OUT OF SPECIFICATION AT THE 0 SETTING WITH NO COMPONENTS BEING REPLACED. AIR DERMATOME, SERIAL NUMBER (B)(4) WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS INSPECTED AND TESTED. THE REPORTED EVENT WAS NON VERIFIABLE DURING THE INITIAL INSPECTION THE SERVICE TECHNICIAN COULD NOT DUPLICATE THE REPORTED EVENT. HOWEVER, THE DEVICE CALIBRATION WAS OUT OF SPECIFICATION AT ZERO SETTING ONLY. WHILE THE AIR DERMATOME WAS RECALIBRATED TO CORRECT THE CALIBRATION BEING OUT OF SPECIFICATION AT THE 0 SETTING, NO COMPONENTS WERE REPLACED AND NO TESTING WAS PERFORM TO TEST HOW IT WOULD TAKE A GRAFT. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. AIR DERMATOME, SERIAL NUMBER (B)(4) WAS TESTED AND RETURNED TO LOANER POOL.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY 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 THE AIR DERMATOME TOOK AN INCONSISTENT GRAFT BOTH VERTICALLY AND HORIZONTALLY THROUGHOUT THE GRAFT. PER THE STAFF THE DERMATOME AUDIBLY SOUNDED OKAY, BUT ENDED UP CUTTING A VERY POOR GRAFT. THERE WAS NO ALTERNATE DEVICE USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785695 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63415159

    Patients

    Seq Age Sex Outcome Treatment
    1