BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7786884 · Received August 15, 2018

    Report

    Report Number
    0001526350-2018-00788
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 30, 2018
    Report Date
    October 8, 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
    AK, US
    Reporter Occupation
    003

    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 UNIT WAS NOT SHAVING SKIN. 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 (B)(6) 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY. THE MOTOR SPEED WAS WITHIN SPECIFICATIONS AND THE CONTROL BAR WAS IN THE CORRECT POSITION. THE CONTROL LEVER TORQUE WAS BELOW SPECIFICATIONS. THE 1 INCH, 2 INCH, AND 3 INCH WIDTH PLATES WERE ALL DEFECTIVE; THEY WOULDN'T FIT OVER THE WIDTH PLATE SCREWS. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON SEPTEMBER 18, 2018 WHICH INCLUDED REPLACEMENT OF THE BALL DETENT, THICKNESS LEVER, BEARINGS, 1 INCH, 2 INCH, AND 3 INCH WIDTH PLATES. AIR DERMATOME, SERIAL NUMBER 113259, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW IT WAS REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY, THE CONTROL LEVER TORQUE WAS BELOW SPECIFICATIONS AND THE 1 INCH, 2 INCH, AND 3 INCH WIDTH PLATES WERE ALL DEFECTIVE; THEY WOULDN'T FIT OVER THE WIDTH PLATE SCREWS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW IT WAS REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY. THE CONTROL LEVER TORQUE WAS BELOW SPECIFICATIONS. THE 1 INCH, 2 INCH, AND 3 INCH WIDTH PLATES WERE ALL DEFECTIVE; THEY WOULDN'T FIT OVER THE WIDTH PLATE SCREWS. 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 · 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 UNIT WAS NOT SHAVING SKIN. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO HARM AND A DELAY LESS THAN 30 MINUTES WAS ASSOCIATED WITH THE EVENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626520 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63669520

    Patients

    Seq Age Sex Outcome Treatment
    1