BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 15111811 · Received July 27, 2022

    Report

    Report Number
    0001526350-2022-00704
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    February 18, 2022
    Report Date
    July 27, 2022
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: TECH CONFIRMED THE REPORTED ISSUE AS THE MOTOR HAD SEIZED DURING ASSESSMENT. ADDITIONALLY THE TECH FOUND THAT THE MACHINED HEAD WAS DAMAGED AND SCREWS WERE WORN, THE UNIT WAS OUT OF CALIBRATION, AND THE CONTROL BAR WAS OUT OF POSITION. TECH REPLACED THE MOTOR, MOTOR SLEEVE, MACHINED HEAD, SHAFT BEARINGS, SLEEVE BEARINGS, SCREWS, AND THEN REPOSITIONED THE CONTROL BAR. TECH TESTED THE UNIT AND RETURNED IT TO SERVICE. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    FOLLOWING SECTIONS WERE UPDATED OR CORRECTED : G3 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HANDPIECE GETS STUCK. DURING INITIAL EVALUATION OF THE DEVICE, THE MOTOR EXHIBITED INCONSISTENT SPEED INCLUDING SEIZING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706902 ZIMMER AIR DERMATOME DERMATOME, PNEUMATICALLY-POWERED GFD ZIMMER SURGICAL, INC. N/A 60223471

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown