BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 8522314 · Received April 17, 2019

    Report

    Report Number
    0001526350-2019-00247
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 13, 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
    ND, US
    Reporter Occupation
    NURSE

    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. THE DEVICE HISTORY RECORD AND PREVIOUS REPAIR RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) WAS REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE RECORD REVIEWS FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. USING THE MACHINE-REPAIR REPORTS AND THE REPAIR SITES FOLDERS ON LIVELINK AS WELL AS SAP TO QUERY FOR ALL REPAIRS ON SERIAL NUMBER (B)(4) PRIOR TO (B)(6) 2019, THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE EVALUATION AND REPAIR. ON (B)(6) 2019, IT WAS REPORTED FROM SANFORD BISMARCK THAT A DERMATOME WAS NOT CUTTING SKIN PROPERLY AND WAS SKIPPING DURING USE ON (B)(6) 2019. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME SERIAL NUMBER 113337 FOR EVALUATION. EVALUATION OF THE DEVICE ON 29 MARCH 2019 NOTED THAT THE CONTROL BAR WAS LOW ON ONE SIDE OF THE DEVICE AND THAT THE DERMATOME WAS OUT OF CALIBRATION SPECIFICATIONS AT THE ZERO SETTING ONLY. THE MOTOR RAN WITHIN MOTOR SPEED SPECIFICATIONS. REPAIR OF THE DERMATOME OCCURRED THE SAME DAY AND INVOLVED REPLACING MULTIPLE BEARINGS AND SETTING THE CONTROL BAR BACK TO THE RIGHT POSITION. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED, AND THEN RETURNED THE DEVICE TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. REFERENCE NUMBER (B)(4) ON (B)(6) 2019. WHILE THE SERVICE TECHNICIAN FOUND THAT THE CONTROL BAR WAS OUT OF POSITION, WHICH WOULD PREVENT THE BLADE FROM SITTING FLUSH WITH THE CONTROL BAR, THEREFORE ALLOWING THE DERMATOME TO TAKE AN IMPROPER GRAFT AND SKIP DURING USE, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE CONTROL BAR TO MOVE OUT OF POSITION. THEREFORE, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE WAS DIDN'T CUT SKIN CORRECTLY, DERMATOME SKIPPED ACROSS SKIN. THE EVENT OCCURRED DURING SURGERY AND THERE WAS A HARM, A DELAY REPORTED. PATIENT HAS TO HAVE A FULL THICKNESS GRAFT TAKEN FROM ANOTHER PART OF THE BODY. NO PERMANENT HARM NOTED. PATIENT HAS WOUND WHERE THE INITIAL GRAFTING WAS ATTEMPTED. THERE WAS A DELAY OF 1-2 HRS. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS DIDN'T CUT SKIN CORRECTLY, DERMATOME SKIPPED ACROSS SKIN. THE EVENT OCCURRED DURING SURGERY AND THERE WAS A HARM, A DELAY REPORTED. PATIENT HAS TO HAVE A FULL THICKNESS GRAFT TAKEN FROM ANOTHER PART OF THE BODY. NO PERMANENT HARM NOTED. PATIENT HAS WOUND WHERE THE INITIAL GRAFTING WAS ATTEMPTED. THERE WAS A DELAY OF 1-2 HRS. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318527 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 63760509

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention