BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7501335 · Received May 9, 2018

    Report

    Report Number
    0001526350-2018-00409
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Report Date
    August 2, 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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE¿S SETTING WAS INCORRECT WHEN USED, TOO THICK. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(4), 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. THIS ISSUE IS BEING FURTHER INVESTIGATED IN AN ISSUE EVALUATION. ZIMMER BIOMET SURGICAL/ MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS. PRODUCT RETURN OF THE AIR DERMATOME BY MEDICREA ON MAY 3, 2018 REVEALED THAT SOME PARTS ARE FROM THE OLDER VERSION. THE MOTOR WAS CORRODED, BUT WITHIN MOTOR SPEED SPECIFICATION AT 5050 RPM. THE CALIBRATION WAS OUT OF SPECIFICATION AT ONLY THE 0 SETTING. THE BLADE POSITION FAILED DURING INCOMING TESTING. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY MEDICREA ON MAY 17, 2018 WHICH INCLUDED REPLACEMENT OF THE BALL BEARINGS, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, AO-RINGS, POPPET HOUSING, POPPET SPRING, THROTTLE HINGE, THROTTLE HINGE GASKET, SEAL SCREWS, POPPET, MOTOR, MOTOR SLEEVE, ALUMINUM LEVER, BALL PLUNGER, RECIPROCATING ARM, THICKNESS CONTROL SHAFT, CONTROL BAR, MACHINE HEAD, SPRING PIN, SET SCREWS, ADJUSTMENT CAMS AND PHSS SCREW. AIR DERMATOME, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE MASTER BLADE POSITION TESTING IS ROUTINE TESTING, THIS DOES NOT MEAN THAT THE CUSTOMER WAS PUTTING ON THE BLADE INCORRECTLY. THE REPORTED EVENT ¿THE DEVICE¿S SETTING WAS INCORRECT WHEN USED, TOO THICK¿ WAS CONFIRMED SINCE DURING INITIAL INSPECTION THE MASTER BLADE WAS NOT IN THE CORRECT POSITION WHICH COULD CAUSE THE DEPTH SETTING TO BE INACCURATE. THE CAUSE OF THE DEVICE¿S SETTINGS BEING TOO THICK WAS DUE TO THE MASTER BLADE FAILURE WHICH COULD CAUSE THE DEPTH SETTING TO BE INACCURATE. THE ROOT CAUSE OF THE DEVICE¿S SETTINGS BEING TOO THICK COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE IT IS UNKNOWN HOW THE BLADE POSITION ENDED UP IN THE INCORRECT POSITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SETTING WAS INCORRECT WHEN USED, TOO THICK. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343922 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1