BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7483917 · Received May 3, 2018

    Report

    Report Number
    0001526350-2018-00391
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 11, 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
    OR, US
    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 MAY 1, 2018, IT WAS REPORTED THAT THE UNIT LEAKS AT THE CONNECTION OR DID NOT WORK. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(4) FOR EVALUATION. THE CUSTOMER ALSO RETURNED A HOSE AND 1¿/2¿/3¿/4¿ WIDTH PLATES, 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. ZIMMER BIOMET SURGICAL HAS NOT PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. PRODUCT REVIEW OF THE AIR DERMATOME ON MAY 5, 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE 0 SETTING ONLY. THE MOTOR DID NOT RUN (0 RPM) AND THE CONTROL BAR WAS IN THE CORRECT POSITION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON MAY 5, 2018 WHICH INCLUDED REPLACEMENT OF THE RECIPROCATING ARM, BEARINGS, SEAL AND RETAINING RING, MOTOR, AND POPPET ASSEMBLY. AIR DERMATOME, SERIAL NUMBER 112906, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW THE MOTOR WAS INOPERATIVE. THE ROOT CAUSE OF THE DEVICE LEAKING AT THE CONNECTION CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION SINCE THERE WERE NO LEAKS FOUND. THE CAUSE OF THE DEVICE NOT WORKING WAS DUE TO THE INOPERATIVE MOTOR. THE ROOT CAUSE OF THE DEVICE NOT WORKING COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE IT IS UNKNOWN HOW THE MOTOR ISSUE 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 · 1

    THIS EVENT IS RECORDED WITH 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 LEAKS AT THE CONNECTION AND/OR DID NOT WORK PRIOR TO SURGERY. THERE WAS NO DELAY AND HARM REPORTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326771 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63415168

    Patients

    Seq Age Sex Outcome Treatment
    1