BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEELED GLENOID TRIAL & DRILL GUIDE CADDY

    MDR report key: 19539299 · Received June 14, 2024

    Report

    Report Number
    1220246-2024-05817
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    March 12, 2021
    Report Date
    June 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867137752
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED. VISUAL INSPECTION IDENTIFIED CORROSION SPOTS INSIDE THE CADDY. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER DETERGENT/CLEANING PROCESS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AGENCY THAT THE FOLLOWING DEVICES ARE CORRODED: AR-9231-01PP QTY (B)(6). AR-9231-02PP QTY (B)(6). AR-9231-03PP QTY (B)(6). AR-9231-04PP QTY (B)(6). AR-9217CPP QTY (B)(6). AR-9225CK QTY (B)(6). AR-9225CP QTY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372971 KEELED GLENOID TRIAL & DRILL GUIDE CADDY MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. KEELED GLENOID TRIAL & DRILL GUIDE CADDY UNK 00888867137752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown