BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7068909 · Received November 29, 2017

    Report

    Report Number
    0001526350-2017-00902
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 20, 2017
    Report Date
    January 18, 2018
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS SUPPLEMENTAL MEDWATCH WAS FILED TO RELAY ADDITIONAL INFORMATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE 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 (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED THIS AIR DERMATOME. INITIAL QA INSPECTION OF THE AIR DERMATOME BY MEDICREA REVEALED THAT ALL PARTS LISTED IN THE QUOTE ARE TO BE CHANGED AS THEY ARE WORN OUT AND DAMAGED. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS BUT WAS OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY MEDICREA WHICH INCLUDED REPLACEMENT OF THE BALL BEARING, O-RING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARING, VESPEL SLEEVE BEARING, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SEAL SCREW, POPPET, MOTOR, MOTOR SLEEVE, CONTROL BAR, THICKNESS CONTROL SHAFT, RECIPROCATING ARM, LEVER, BALL PLUNGER AND FINE ADJUSTMENT CAM. THE AIR DERMATOME WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE INITIAL INSPECTION BY MEDICREA IT WAS NOTED THAT MANY OF THE PARTS WERE WORN OUT/DAMAGED AND THE DEVICE WAS OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE INITIAL INSPECTION BY MEDICREA IT WAS NOTED THAT MANY OF THE PARTS WERE WORN OUT/DAMAGED AND THE DEVICE WAS OUTSIDE CALIBRATION AND SIDE TO SIDE SPECIFICATIONS. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. THE AIR DERMATOME WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY 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 HARVESTED GRAFT WAS NOT USABLE AND AN ADDITIONAL GRAFT WAS TAKEN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT PRODUCT A HOMOGENEOUS CUT DURING SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848547 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 61197709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention