BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO TORNADO HP W HANDCONTROL

    MDR report key: 8686702 · Received June 11, 2019

    Report

    Report Number
    1221934-2019-57318
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 21, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705016938
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT SERVICE CENTER AND EVALUATED. THE CUSTOMER REPORTED AN ARTICLE DEFECT, A PLASTIC PART WAS PRESENT IN THE HEAD, THEREFORE WE CAN CONFIRM THIS COMPLAINT AS A DEFECT WAS FOUND WITH THE COMPLAINT DEVICE. THE UNIT HAS BEEN CHECKED FOR TECHNICAL SAFETY. NO TECHNICAL OR FUNCTIONAL FAULTS WERE FOUND IN THE FUNCTIONAL TESTS CARRIED OUT ON THE UNIT. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE IDENTIFIED FAILURE. THE SERVICE HISTORY HAS BEEN REVIEWED IN LIEU OF THE DEVICE HISTORY RECORD FOR THIS DEVICE SINCE IT WAS PREVIOUSLY SERVICED. THE DEVICE WAS LAST SERVICED ON 07/24/2018 AND PASSED ALL FUNCTIONAL TESTING BEFORE BEING RETURNED TO THE CUSTOMER. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT THE MICRO TORNADO HANDPIECE WITH HAND CONTROLS HAS AN ARTICLE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480709 MICRO TORNADO HP W HANDCONTROL LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM HRX DEPUY MITEK LLC US 10886705016938

    Patients

    Seq Age Sex Outcome Treatment
    1