BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 7776335 · Received August 13, 2018

    Report

    Report Number
    0001526350-2018-00630
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    June 30, 2018
    Report Date
    October 16, 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
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). CONCLUSION SUMMARY: ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE HAD INTERMITTENT OPERATION. THE CUSTOMER DID NOT RETURN AN ELECTRIC DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR AND PREVIOUS REPAIR REPORT REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ZIMMER BIOMET SURGICAL HAS PREVIOUSLY REPAIRED/EVALUATED ELECTRIC DERMATOME SERIAL NUMBER 203226 THREE TIMES AS DOCUMENTED IN THE REPAIR REPORTS IN LIVELINK. THE LAST REPAIR WAS AUGUST 12, 2016 WHERE IT WAS REPORTED THAT THE MOTOR SLOWS DOWN AND STOPS AND THE STANDARD REPAIR PARTS WERE REPLACED. THIS IS NOT A RELATED ISSUE. PRODUCT REVIEW OF THE ELECTRIC DERMATOME WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. REPAIR OF THE ELECTRIC DERMATOME WAS NOT PERFORMED BY ZIMMER BIOMET SURGICAL AS THE DEVICE WAS NOT RETURNED FOR REPAIR. THE REPORTED EVENT WAS NON-VERIFIABLE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION OR REPAIR. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION OR REPAIR. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. 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 IS RECORDED WITH 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 THE DEVICE HAD INTERMITTENT OPERATION. THE EVENT OCCURRED POST-OP TESTING. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617140 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 60642478

    Patients

    Seq Age Sex Outcome Treatment
    1