BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8915752 · Received August 21, 2019

    Report

    Report Number
    0001526350-2019-00671
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    July 29, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THIS REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING FIELDS WERE UPDATED/ CORRECTED: B2, B4, B5, D4, D10, G4, G7, H1, H2, H3, H4, H6, H10. D4: UDI #: (B)(4). 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. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER 113397, FOR EVALUATION. THE CUSTOMER ALSO RETURNED A HOSE AND 1"/2"/3"/4" WIDTH PLATES, FOR EVALUATION. PRODUCT REVIEW OF THE AIR DERMATOME ON AUGUST 13, 2019 REVEALED THAT THE SPRING SEAL WAS DAMAGED CAUSING THE MOTOR TO RUN ERRATICALLY. THE TORQUE ON THE THICKNESS ADJUSTMENT LEVER WAS LOW. THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE ZERO SETTING ONLY AND THE CONTROL BAR WAS IN THE CORRECT POSITION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON AUGUST 13, 2019 WHICH INCLUDED REPLACEMENT OF THE SEMI-CIRCLE BEARINGS, VESPEL BEARINGS, BEARINGS, AND SPRING SEAL. AIR DERMATOME, SERIAL NUMBER 113397, WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE AIR DERMATOME WAS TAKING SKIN IRREGULARLY DUE TO THE SPRING SEAL BECOMING DAMAGED AND THEN CAUSING THE MOTOR TO RUN ERRATICALLY, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT ACTUALLY CAUSED THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE SEMI-CIRCLE BEARINGS, VESPEL BEARINGS, BEARINGS, AND SPRING SEAL WERE REPLACED. 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 · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD TAKEN SKIN IRREGULARLY. THE EVENT OCCURRED DURING SURGERY AND THERE WAS A HARM REPORTED. THERE WAS A DELAY OF 30 MIN TO GET A NEW DEVICE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOREIGN - (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD TAKEN SKIN IRREGULARLY. THE EVENT OCCURRED DURING SURGERY AND THERE WAS A HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708544 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63817647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R