BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH, PEGGED GLENOID

    MDR report key: 19078511 · Received April 10, 2024

    Report

    Report Number
    1220246-2024-01936
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    October 12, 2020
    Report Date
    April 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867059443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    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. THE COMPLAINT COULD NOT BE CONFIRMED. ONE UNPACKAGED AR-9233, BATCH 051614 BROACH WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING IDENTIFIED THAT THE BROACH COULD BE SLID BOTH UP AND DOWN THE SHAFT, WITH NO STICKING OBSERVED. VISUAL INSPECTION DID NOT REVEAL ANY BLOOD/TISSUE REMNANTS. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    PER LOAN / CONSIGNMENT INSPECTIONS OPERATOR: THE INSTRUMENT CANNOT BE DISASSEMBLED AND IS DIFFICULT TO CLEAN, THEREFORE BIOLOGICAL RESIDUES SUCH AS BLOOD ACCUMULATE INSIDE THE INSTRUMENT AND BY MOVING THE "OUTER ROD", BLOOD RESIDUES CAN BE SEEN AT THE DISTAL END. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105245 BROACH, PEGGED GLENOID MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. BROACH, PEGGED GLENOID 051614 00888867059443

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown