BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7283051 · Received February 20, 2018

    Report

    Report Number
    0001526350-2018-00155
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    January 25, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    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. ON JANUARY 20, 2018, IT WAS REPORTED THAT THE DEVICE LOST PRESSURE. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) ONCE AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(6) 2016 WHERE IT WAS REPORTED THAT THE DEVICE REQUIRED MAINTENANCE AND THE MOTOR, MOTOR SLEEVE, LEVER, RECIPROCATING ARM, CONTROL BAR, LEVER, BALL PLUNGER, CONTROL BAR AND ALL USUAL WEARING PARTS WERE REPLACED. THIS IS NOT A RELATED ISSUE. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR AND PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. INITIAL QA INSPECTION OF THE AIR DERMATOME BY MEDICREA ON (B)(6) 2018 REVEALED THAT THE BALL BEARINGS, O-RINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SCREWS, POPPET, MOTOR, MOTOR SLEEVE, RECIPROCATING ARM, AND ADJUSTMENT CAM WERE ALL DAMAGED OR WORN. THE MOTOR WAS AT 0 RPM AND THE DEVICE WAS OUT OF CALIBRATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY MEDICREA ON (B)(6) 2018 WHICH INCLUDED REPLACEMENT OF THE BALL BEARINGS, O-RINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SCREWS, POPPET, MOTOR, MOTOR SLEEVE, RECIPROCATING ARM, AND ADJUSTMENT CAM. AIR DERMATOME, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING INITIAL INSPECTION THE MOTOR WAS AT 0 RPM. THE DEVICE DID NOT HAVE ANY PRESSURE LOST. THE ROOT CAUSE OF THE DEVICE LOSING PRESSURE COULD NOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION. HOWEVER, DURING INITIAL INSPECTION THE MOTOR WAS INOPERATIVE. THE MOTOR BEING INOPERATIVE WOULD CAUSE AIR TO FLOW THROUGH THE MOTOR WHICH MAKE THE MOTOR NOT DRIVE THE RECIPROCATING ARM ASSEMBLY. WHEN THE DEVICE WOULD THEN BE USED, THE DEVICE WOULD APPEAR THAT THE NECESSARY AIR PRESSURE IS NOT BEING PROVIDED. 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 REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. NO FURTHER CONCLUSIONS CAN BE DRAWN FROM THE COMPLAINT HISTORY REVIEW THAT WARRANTS FURTHER ACTION.

    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.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE LOST PRESSURE. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. (B)(4) HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) ONCE AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(6) 2016 WHERE IT WAS REPORTED THAT THE DEVICE REQUIRED MAINTENANCE AND THE MOTOR, MOTOR SLEEVE, LEVER, RECIPROCATING ARM, CONTROL BAR, LEVER, BALL PLUNGER, CONTROL BAR AND ALL USUAL WEARING PARTS WERE REPLACED. THIS IS NOT A RELATED ISSUE. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR AND PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. INITIAL QA INSPECTION OF THE AIR DERMATOME BY (B)(4) ON FEBRUARY 6, 2018 REVEALED THAT THE BALL BEARINGS, O-RINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SCREWS, POPPET, MOTOR, MOTOR SLEEVE, RECIPROCATING ARM, AND ADJUSTMENT CAM WERE ALL DAMAGED OR WORN. THE MOTOR WAS AT 0 RPM AND THE DEVICE WAS OUT OF CALIBRATION. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY (B)(4) ON FEBRUARY 12, 2018 WHICH INCLUDED REPLACEMENT OF THE BALL BEARINGS, O-RINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SCREWS, POPPET, MOTOR, MOTOR SLEEVE, RECIPROCATING ARM, AND ADJUSTMENT CAM. AIR DERMATOME, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING INITIAL INSPECTION THE MOTOR WAS AT 0 RPM. THE ROOT CAUSE OF THE DEVICE LOSING PRESSURE WAS DUE TO THE MOTOR BEING INOPERATIVE. THE MOTOR RUNNING BELOW SPECIFICATION WOULD CAUSE THE DEVICE TO NOT FUNCTION AS INTENDED. 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 REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. NO FURTHER CONCLUSIONS CAN BE DRAWN FROM THE COMPLAINT HISTORY REVIEW THAT WARRANTS FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR DERMATOME LOST PRESSURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126804 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 61707970

    Patients

    Seq Age Sex Outcome Treatment
    1