BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 6257548 · Received January 17, 2017

    Report

    Report Number
    0001526350-2017-00021
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 11, 2017
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-XXXXXXX. THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. ON (B)(6) 2017, IT WAS REPORTED THAT WHEN USING THE DEVICE TO TAKE A GRAFT FROM THE LEFT THIGH THE BLADE CAUSED A LACERATION THRU THE DERMIS. CLINICAL FOLLOW UP WAS CONDUCTED TO CLARIFY ANY ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT HOWEVER, THE CUSTOMER WAS UNRESPONSIVE. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER 100501, FOR EVALUATION. THE CUSTOMER ALSO RETURNED A HOSE AND 1¿/2¿/3¿/4¿ WIDTH PLATES, FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE DHR ASSOCIATED WITH THIS SERIALIZED DEVICE WAS UNAVAILABLE FOR REVIEW AT THE TIME OF PROCESSING THIS COMPLAINT. ZIMMER BIOMET SURGICAL HAS NOT PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. INITIAL QA INSPECTION OF THE AIR DERMATOME ON JANUARY 9, 2017 REVEALED THAT THE CONTROL BAR WAS BELOW THE CORRECT POSITION ON THE LEFT SIDE AND CALIBRATION WAS OUT OF SPECIFICATION ON THE HIGH SIDE, BOTH OF WHICH COULD CAUSE LACERATIONS. THE HEAD, CONTROL BAR, CALIBRATION SHAFT, AIR HOSE, AND ALL 4 WIDTH PLATES WERE DAMAGED. ON JANUARY 9, 2017 AIR DERMATOME, SERIAL NUMBER (B)(4), WAS DEEMED TOO OLD TO BE REPAIRED PROPERLY AND WAS THEREFORE NON-REPAIRABLE. THE REPORTED EVENT WAS CONFIRMED SINCE DURING INITIAL INSPECTION IT WAS REVEALED THAT THE CONTROL BAR WAS BELOW THE CORRECT POSITION ON THE LEFT SIDE AND CALIBRATION WAS OUT OF SPECIFICATION ON THE HIGH SIDE. THE REPORTED EVENT WAS CONFIRMED SINCE DURING INITIAL INSPECTION IT WAS REVEALED THAT THE CONTROL BAR WAS BELOW THE CORRECT POSITION ON THE LEFT SIDE AND CALIBRATION WAS OUT OF SPECIFICATION ON THE HIGH SIDE. IT IS UN KNOW WHY THE CONTROL BAR WAS DISPOSITIONED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. THE ISSUE WAS NOT RESOLVED BECAUSE THE UNIT IS NON-REPAIRABLE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. AIR DERMATOME, SERIAL NUMBER (B)(4), WAS TESTED AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. INITIAL QA INSPECTION OF THE AIR DERMATOME ON JANUARY 9, 2017 REVEALED THAT THE CONTROL BAR WAS BELOW THE CORRECT POSITION ON THE LEFT SIDE AND CALIBRATION WAS OUT OF SPECIFICATION ON THE HIGH SIDE, BOTH OF WHICH COULD CAUSE LACERATIONS. THE HEAD, CONTROL BAR, CALIBRATION SHAFT, AIR HOSE, AND ALL 4 WIDTH PLATES WERE DAMAGED. ON JANUARY 9, 2017, THE AIR DERMATOME WAS DEEMED TOO OLD TO BE REPAIRED PROPERLY AND WAS THEREFORE NON-REPAIRABLE. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND A ROOT CAUSE HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE DERMATOME TO TAKE A SKIN GRAFT ON THE PATIENT'S LEFT THIGH, IT MALFUNCTIONED DURING INITIAL USE. THE BLADE CAUSED A LACERATION THROUGH THE DERMIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39308 ZIMMER AIR DERMATOME AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other