BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON SHARP MICRO NERVE HOOK

    MDR report key: 6935624 · Received October 10, 2017

    Report

    Report Number
    MW5072654
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 14, 2017
    Report Date
    October 5, 2017
    Manufacturer
    FISCHER SURGICAL, INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING SURGERY, PIECE OF RHOTON SHARP MICRO NERVE HOOK BROKE OFF IN PT. UNABLE TO LOCATE PRIOR TO END OF CASE AND CLOSURE OF WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718883 RHOTON SHARP MICRO NERVE HOOK NERVE HOOK GDG FISCHER SURGICAL, INC. FW-4700

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other