BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 6442701 · Received March 29, 2017

    Report

    Report Number
    0001526350-2017-00143
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    March 2, 2017
    Report Date
    December 6, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). 101928, 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. THIS ISSUE IS BEING FURTHER INVESTIGATED IN ISSUE EVALUATION IE-03394. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED AIR DERMATOME SERIAL NUMBER (B)(4) ONE TIME AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(6), 2012 WHERE IT WAS REPORTED THAT THE DEVICE WAS SENT IN FOR PREVENTATIVE MAINTENANCE AND THE BALL DETENT, DAMAGED HEAD, DAMAGED CONTROL BAR, THICKNESS LEVER, RECIPROCATING ARM, BEARINGS, SEAL AND RETAINING RING, MOTOR, SWIVEL, POPPET ASSEMBLY, HAND PIECE ASSEMBLY, HOSE, SCREW DRIVER, WIDTH PLATES, AND O-RING WERE REPLACED. THIS IS NOT A RELATED ISSUE. INITIAL QA INSPECTION OF THE AIR DERMATOME ON (B)(6), 2017 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AND THE MOTOR SPEED WAS NOT WITHIN SPECIFICATION AND RAN ERRATICALLY. IT WAS ALSO NOTED THAT THE DEVICE HAD NOT BEEN IN FOR REPAIR SINCE (B)(6) 2012. REPAIR OF THE AIR DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6), 2017 WHICH INCLUDED REPLACEMENT OF THE BALL DETENT, THICKNESS LEVER, RECIPROCATING ARM, BEARINGS, SEAL AND RETAINING RING, MOTOR, POPPET ASSEMBLY, O-RING, AND CALIBRATION SHAFT. 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 IT WAS REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AND THE MOTOR SPEED WAS NOT WITHIN SPECIFICATION AND RAN ERRATICALLY. HOWEVER, IT WAS ALSO NOTED THAT THE DEVICE HAD NOT BEEN IN FOR REPAIR SINCE (B)(6) 2012. THE ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO MOTOR SINCE DURING INITIAL INSPECTION IT WAS REVEALED THAT THE MOTOR SPEED WAS NOT WITHIN SPECIFICATION AND RAN ERRATICALLY. HOWEVER, IT WAS ALSO NOTED THAT THE DEVICE HAD NOT BEEN IN FOR REPAIR SINCE (B)(6) 2012. THE ISSUE WAS RESOLVED WITH REPLACEMENT OF THE BALL DETENT, THICKNESS LEVER, RECIPROCATING ARM, BEARINGS, SEAL AND RETAINING RING, MOTOR, POPPET ASSEMBLY, O-RING, AND CALIBRATION SHAFT. 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (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. RECEIVED; HOWEVER, NOT YET EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS MALFUNCTIONING DURING SURGERY. THE HARVESTED GRAFT WAS NOT USEABLE AND AN ADDITIONAL GRAFT WAS REQUIRED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227026 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other