BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 14464109 · Received May 20, 2022

    Report

    Report Number
    3003898228-2022-00007
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    December 22, 2021
    Report Date
    August 4, 2022
    Manufacturer
    FH INDUSTRIE
    Product Code
    PHX
    UDI-DI
    03661489694806
    PMA / PMN Number
    K171789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE ARE SOME SCRATCH AND BURR INSIDE THE HOLE; SO THIS ONE IS NOT ABLE TO PASS THROUGH REAMER.

    Description of Event or Problem · 0

    THERE ARE SOME SCRATCH AND BURR INSIDE THE HOLE; SO THIS ONE IS NOT ABLE TO PASS THROUGH REAMER.

    Description of Event or Problem · 0

    THERE ARE SOME SCRATCH AND BURR INSIDE THE HOLE; SO THIS ONE IS NOT ABLE TO PASS THROUGH REAMER.

    Description of Event or Problem · 0

    THERE ARE SOME SCRATCH AND BURR INSIDE THE HOLE; SO THIS ONE IS NOT ABLE TO PASS THROUGH REAMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563562 ARROW ARROW TAPERED DRILL GUIDE MB S44 PHX FH INDUSTRIE 269483 CM24299 03661489694806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown