BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 9538615 · Received January 2, 2020

    Report

    Report Number
    0001526350-2020-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    October 7, 2019
    Report Date
    January 30, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD (DHR) REVIEW FOR THE AIR DERMATOME, PART NUMBER 00880100100, WILL NOT BE REVIEWED AS A LIMITED INVESTIGATION IS BEING PERFORMED FOR THIS COMPLAINT. THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA AND COMPLAINTS ARE MONITORED THROUGH MONTHLY MEETINGS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. ON (B)(6) 2019, IT WAS REPORTED THAT THE UNIT WAS OSCILLATING WHEN CONNECTED BUT WOULD CEASE WHEN ENGAGED FOR HARVESTING. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(6), FOR EVALUATION. PRODUCT REVIEW OF THE AIR DERMATOME ON DECEMBER 19, 2019 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY. THE MOTOR SPEED WAS WITHIN SPECIFICATION AND THE CONTROL BAR WAS IN THE CORRECT POSITION. THE CUSTOMER HOSE AND WIDTH PLATES WERE NOT RETURNED FOR EVALUATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED ON DECEMBER 19, 2019 WHICH INCLUDED REPLACEMENT OF THE NEEDLE BEARING, RECIPROCATING ARM, SWIVEL, MOTOR, BALL BEARINGS, INTERNAL RETAINING RING, AND SPRING SEAL. AIR DERMATOME, SERIAL NUMBER 111615, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE REPORTED EVENT WAS NOT ABLE TO BE REPRODUCED DURING EVALUATION. IT WAS FOUND THAT THE CALIBRATION WAS OUT OF CALIBRATION AT THE ZERO SETTING ONLY, HOWEVER, A GRAFT CANNOT BE TAKEN AT THE ZERO SETTING SO IT DOES NOT IMPACT THE FUNCTION OF THE DEVICE. THE NEEDLE BEARING, RECIPROCATING ARM, SWIVEL, MOTOR, BALL BEARINGS, INTERNAL RETAINING RING, AND SPRING SEAL WERE REPLACED PROACTIVELY. 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

    IT WAS REPORTED THAT THE UNIT WAS OSCILATING WHEN CONNECTED BUT WOULD CEASE WHEN ENGAGED FOR HARVESTING. DURING EVALUATION OF THE DEVICE, NO PROBLEMS COULD BE FOUND WITH THE DEVICE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PRODUCT HAS BEEN 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 UNIT WAS OSCILATING WHEN CONNECTED BUT WOULD CEASE WHEN ENGAGED FOR HARVESTING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 62689593

    Patients

    Seq Age Sex Outcome Treatment
    1