BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7286720 · Received February 21, 2018

    Report

    Report Number
    0001526350-2018-00171
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Report Date
    April 3, 2018
    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
    AS
    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. ON (B)(6) 2018, IT WAS REPORTED THAT THE TWO DERMATOMES WERE NOT WORKING PROPERLY AND THE SKIN COMING WAS VERY THIN WHEN THEY ADJUSTED THE EQUIPMENT. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) TWICE AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(6), 2009 WHERE IT WAS REPORTED THAT THE DERMATOME WAS NOT WORKING PROPERLY AND THE SKIN WAS COMING UP VERY THIN AND THE BEARINGS, CALIBRATING SHAFT, O-RING, SEAL AND RETAINING RING AND HEADPIECE ASSEMBLY WERE REPLACED. THE DEVICE HISTORY RECORD (DHR) NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. INITIAL QA INSPECTION OF THE AIR DERMATOME BY ZIMMER BIOMET AUSTRALIA ON (B)(6), 2018 REVEALED THAT THE HEAD WAS WORN AND THERE WAS SOME SIDE PLAY WITH THE DEPTH BAR. THE MOTOR WAS AT 0 RPM AND LOOKED CORRODED ON THE OUTSIDE. THE BALL BEARING ON THE SHAFT WAS CORRODED AS WELL. THE CONTROL LEVER TORQUE TESTING WAS NOT PERFORMED. THE DEVICE WAS OUT OF CALIBRATION AT ALL FOUR SETTINGS. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET AUSTRALIA ON (B)(6), 2018 WHICH INCLUDED REPLACEMENT OF THE HEAD, SEMI-CIRCLE BEARINGS, MOTOR, MOTOR SLEEVE, BALL BEARING, SPRING SEAL, EXTERNAL E-RING, RECIPROCATING ARM AND WIDTH PLATE SCREW. AIR DERMATOME, SERIAL NUMBER (B)(6), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING INITIAL INSPECTION THE MOTOR WAS INOPERATIVE, THERE WAS SIDE PLAY TO THE DEPTH BAR AND THE DEVICE WAS OUT OF CALIBRATION. THE ROOT CAUSE OF THE DEVICE NOT WORKING PROPERLY WAS DUE TO THE MOTOR BEING INOPERATIVE AND CORRODED. THE MOST LIKELY CAUSE OF THE DEVICE BEING CORRODED IS IMPROPER CLEANING, HOWEVER IT IS UNKNOWN HOW THE MOTOR ISSUE OCCURRED. THE ROOT CAUSE OF THE SKIN COMING OFF VERY THIN WAS DUE TO THE DEPTH BAR HAVING SOME PLAY AND THE DEVICE BEING OUT OF CALIBRATION. IT IS UNKNOWN HOW THE DEPTH BAR AND CALIBRATION ISSUES OCCURRED, HOWEVER IF THE DEPTH BAR IS LOOSE AND THE DEVICE IS OUT OF CALIBRATION THE DEVICE COULD PRODUCE LESS THAN OPTIMAL SKIN GRAFTS THE ISSUE WAS RESOLVED WITH THE REPLACED LEVEL SENSOR. IMPROPER CLEANING MAY ALSO AFFECT THE CALIBRATION OF THE DEVICE. 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 REPAIRED, TESTED AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-(B)(4). A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND A ROOT CAUSE HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY TWO PLASTIC SURGEONS THAT THE DERMATOME WAS NOT WORKING PROPERLY AND THE SKIN COMING UP WAS VERY THIN WHEN THEY ADJUSTED THE EQUIPMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129933 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 31609500

    Patients

    Seq Age Sex Outcome Treatment
    1