BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 19472605 · Received June 5, 2024

    Report

    Report Number
    1220246-2024-04994
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    June 20, 2022
    Report Date
    June 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867060333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE BY MEANS OF USER-APPLIED MECHANICAL FORCES.  AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED. THIS COMPLAINT WILL BE INCLUDED IN TRENDING PER (B)(4).

    Description of Event or Problem · 0

    ON 6/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9401-17 EXTRACTOR IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822824 ECLIPSE HUMERAL HEAD EXTRACTOR MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR UNK 00888867060333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown