BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 11475109 · Received March 12, 2021

    Report

    Report Number
    1220246-2021-02704
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    January 22, 2021
    Report Date
    March 12, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867060333
    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 TIP OF THE DEVICE WAS FOUND TO BE DAMAGED. A FRAGMENT BROKE OFF AND WAS NOT RETURNED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER THE LIKELIEST CAUSE OF THE OBSERVED FAILURE MODE IS USER-APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AR-9401-17 HUMERAL HEAD EXTRACTOR IS DAMAGED. ADDITIONAL INFORMATION RECEIVED ON 1/27/2021: THE REP REPORTED DAMAGE TO THE DEVICE DID NOT HAPPEN DURING A CASE. THE ISSUE WAS NOTICED BY A STERILE PROCESSING TECH DURING INSPECTION PRIOR TO A CASE. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED, THE TIP OF THE DEVICE WAS FOUND TO BE DAMAGED. A FRAGMENT BROKE OFF AND WAS NOT RETURNED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER THE LIKELIEST CAUSE OF THE OBSERVED FAILURE MODE IS USER-APPLIED MECHANICAL FORCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375018 ECLIPSE HUMERAL HEAD EXTRACTOR INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR 250111203 00888867060333

    Patients

    Seq Age Sex Outcome Treatment
    1