BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 12010850 · Received June 16, 2021

    Report

    Report Number
    3003898228-2021-00001
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 19, 2021
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWS
    PMA / PMN Number
    K171789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING THE PREPARATION OF THE GLENOID, WHEN DRILLING THE HOLES FOR THE PREPARATION, THERE WAS RESISTANCE TO DRILLING. THE TAPERED REAMER TWISTED IN THE DRILL GUIDE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907578 ARROW ARROW QUICK RELEASE TAPERED REAMER KWS FH INDUSTRIE 269480 CM21885

    Patients

    Seq Age Sex Outcome Treatment
    1