BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH, PEGGED GLENOID

    MDR report key: 13758332 · Received March 14, 2022

    Report

    Report Number
    1220246-2022-04608
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867059443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9233, BATCH 051614 WAS RECEIVED FOR INVESTIGATION. THE VISUAL INSPECTION IDENTIFIED WELD FAILURE BETWEEN THE ANVIL AND BROACH, AND WEAR AND TEAR ON THE OVERALL DEVICE. THE CAUSE IS LIKELY DUE TO REPEATED USE OVER TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT WHEN USING THE AR-9233 PEGGED GLENOID BROACH THE CYLINDER PLATE ON THE BACK OF THE HANDLE WHERE THE MALLET MAKES CONTACT BROKE OFF. THIS WAS DISCOVERED IN USE DURING THE BROACHING STEP FOR THE VAULTLOCK IMPLANT IN A SHOULDER PROCEDURE ON (B)(6) 2022. BROACHING WAS STILL COMPLETE, AND NO FURTHER IMPACTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364500 BROACH, PEGGED GLENOID INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. BROACH, PEGGED GLENOID 051614 00888867059443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown