BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID DRILL GUIDE HANDLE, LONG

    MDR report key: 11585411 · Received March 29, 2021

    Report

    Report Number
    1220246-2021-02788
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 29, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867059023
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED, THE DISTAL END OF THE THREADED TIP IS CHIPPED. THE DEVICE LASER MARKINGS WERE FOUND TO BE FADED. THE DEVICE WAS FOUND TO MEET MATERIAL SPECIFICATION AND THE MAJOR DIAMETER ALSO MET SPECIFICATIONS. THE CAUSE IS UNDETERMINED, HOWEVER A LIKELY CAUSE IS USER-APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT THE AR-9215-01-02, GUIDE HANDLE HAS A CRACK IN THE THREADING. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484084 GLENOID DRILL GUIDE HANDLE, LONG INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. GLENOID DRILL GUIDE HANDLE, LONG 4461511 00888867059023

    Patients

    Seq Age Sex Outcome Treatment
    1