BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCI S&N POW/POW MAX

    MDR report key: 13695239 · Received March 8, 2022

    Report

    Report Number
    1221934-2022-00781
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    January 7, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND TESTED. VISUAL OBSERVATION REVEALED THE CABLE AND INTERNAL WIRING IS BROKE AND EXPOSED. ALTHOUGH WE CANNOT DETERMINE AT WHAT POINT IN TIME THE CABLE BROKE, IT CAN BE CONCLUDED THAT THIS IS THE ROOT CAUSE FOR THE FAILURE OF THE DEVICE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE HCI S&N POW/POW MAX CABLE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CABLE AND INTERNAL WIRING WERE BROKEN AND EXPOSED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260226 HCI S&N POW/POW MAX LINE-POWERED SHAVER SYSTEM HANDPIECE ELECTRICAL CABLE HRX DEPUY MITEK LLC US C42AF0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown