BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 7195971 · Received January 16, 2018

    Report

    Report Number
    0001526350-2018-00055
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 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
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. ON JANUARY 8, 2018, IT WAS REPORTED THAT AFTER CONNECTING TO THE POWER SUPPLY THE PRODUCT WORKED, BUT IT STOPPED WORKING DURING TRANSPLANTATION. THE CUSTOMER RETURNED AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO DID NOT RETURN A POWER SUPPLY. 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. ZIMMER BIOMET SURGICAL/ MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER (B)(4) FOUR TIMES AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS (B)(6) 2015 WHERE IT WAS REPORTED THAT THE DEVICE WAS NOT TAKING SKIN AND THE BALL BEARING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, MOTOR AND DIVERS WERE REPLACED. THIS IS NOT A RELATED ISSUE. INITIAL QA INSPECTION OF THE ELECTRIC DERMATOME BY MEDICREA ON (B)(6) 2018 REVEALED THAT THE BALL BEARING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, MOTOR, CONTROL BAR, THICKNESS CONTROL SHAFT, ADJUSTMENT CAM, LEVER ETCHED, SCREWS, AND DIVERS WERE ALL DAMAGED. THE DEVICE WAS OUT OF CALIBRATION AT ALL FOUR SETTINGS. THE MOTOR WAS AT 0 RPM. REPAIR OF THE ELECTRIC DERMATOME WAS PERFORMED BY MEDICREA ON (B)(6) 2018 WHICH INCLUDED REPLACEMENT OF THE BALL BEARING, SPRING SEAL, NEEDLE BEARING, SEMI-CIRCLE BEARINGS, VESPEL SLEEVE BEARINGS, MOTOR, CONTROL BAR, THICKNESS CONTROL SHAFT, ADJUSTMENT CAM, LEVER ETCHED, SCREWS, AND DIVERS. 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 AT 0 RPM. THE ROOT CAUSE WAS DUE TO THE MOTOR MALFUNCTIONING. THE SERVICE TECHNICIAN CONFIRMED DURING THE INITIAL INSPECTION OF THE DEVICE WHEN THE SERVICE TECHNICIAN FOUND THAT THE MOTOR SPEED WAS AT 0 RPM. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. ELECTRIC 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CONNECTING A POWER SUPPLY THE PRODUCT WORKED, BUT IT STOPPED WORKING DURING SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39027 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 32459400

    Patients

    Seq Age Sex Outcome Treatment
    1