BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 16709648 · Received April 10, 2023

    Report

    Report Number
    0001526350-2023-00357
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375994
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-0871453. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN CORRECTED/UPDATED: A1, B4, B5, D2, D4, D9, G1, G3, G6, H1, H3, H4, H6, H10. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE RPMS WERE IN SPEC; HOWEVER, THE DEVICE LOST SOME POWER AFTER RUNNING. THE MOTOR, PLUG HARNESS ASSEMBLY, SWITCH, AND SPRING SEAL WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DERMATOME LOSES POWER. THE ISSUE DID NOT OCCUR DURING SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532600 HANDPIECE, ELECTRIC DERMATOME DERMATOME HANDPIECE, ELECTRICALLY POWERED GFD ZIMMER SURGICAL, INC. N/A 65057363 00889024375994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown