BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVECARE +SFT SYSTEM WARNING:

    MDR report key: 12144623 · Received July 9, 2021

    Report

    Report Number
    0001526350-2021-00785
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    April 29, 2021
    Report Date
    October 4, 2021
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE INVESTIGATION IS COMPLETE. THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION CONFIRMED BREAKAGE IN THE CORD, EXPOSING THE COPPER WIRING. LOT/SERIAL IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, AND LOT/SERIAL IDENTIFICATION WAS NOT PROVIDED. DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE EVENT IS CONFIRMED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP/FINAL REPORT WILL BE SENT. PRODUCT CODE - JOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGING CORD HAD EXPOSED WIRES ON IT. THE EVENT TIMING WAS DURING TESTING. THERE WAS NO HARM OR DELAY. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044948 ACTIVECARE +SFT SYSTEM WARNING: SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1