BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 7453754 · Received April 24, 2018

    Report

    Report Number
    0001526350-2018-00339
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 18, 2018
    Report Date
    May 11, 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
    SA
    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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, B4, D4, D10, G4, G7, H2, H3, H4, H6, H10. D4: (B)(4). ON (B)(6), 2018, IT WAS REPORTED THAT DURING SURGERY THE DEVICE STOPPED WORKING. ON (B)(6), 2018, IT WAS CLARIFIED THAT THE ISSUE OCCURRED ON (B)(6), 2018. THE EVENT WAS IDENTIFIED AFTER A RECENT PURCHASE OR REPAIR. THERE WAS NO MEDICAL INTERVENTION OR ADDITIONAL SURGICAL PROCEDURES REQUIRED. THERE WAS NO HARM OR INJURY REPORTED. ANOTHER DEVICE WAS NOT USED TO COMPLETE THE SURGERY. THERE WAS NO EXTENSION OR DELAY REPORTED. THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS FOLLOWED. AN ADDITIONAL UNPLANNED SKIN GRAFT WAS NOT REQUIRED. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ZIMMER BIOMET SURGICAL HAS NOT PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. PRODUCT REVIEW OF THE ELECTRIC DERMATOME ON MAY 5, 2018 REVEALED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE 0 SETTING ONLY. THE MOTOR DID NOT RUN SO THE MOTOR SPEED COULD NOT BE MEASURED (0 RPM). THE CONTROL BAR WAS LOW. THE CUSTOMER DID NOT RETURN A POWER SUPPLY FOR EVALUATION. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON MAY 5, 2018 WHICH INCLUDED REPLACEMENT OF THE POWER CORD ASSEMBLY, POWER SWITCH, BELL DETENT, THICKNESS LEVER, RECIPROCATING ARM, BEARINGS, SEAL AND RETAINING RING, MOTOR, AND O-RING, DAMAGED HEAD, DAMAGED CONTROL BAR, AND CALIBRATION SHAFT. ELECTRIC 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 INOPERATIVE. THE CAUSE OF THE DEVICE STOPPING DURING SURGERY WAS DUE TO THE INOPERATIVE MOTOR. THE ROOT CAUSE OF THE DEVICE STOPPING DURING SURGERY COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE IT IS UNKNOWN HOW THE MOTOR ISSUE OCCURRED. THE ISSUE WAS RESOLVED WITH THE REPLACED MOTOR. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND A ROOT CAUSE HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE ZIMMER ELECTRIC DERMATOME HANDPIECE (PN # 00-8821-001, SERIAL NO. (B)(4) /02-MENTIONED IN THE HAND PIECE) SUDDENLY STOPPED. SO CUSTOMER DECIDED TO PROCEED BY MANUAL SKIN GRAFT PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296412 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 63574779

    Patients

    Seq Age Sex Outcome Treatment
    1