BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 15665581 · Received October 25, 2022

    Report

    Report Number
    1627487-2022-05841
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    October 13, 2022
    Report Date
    August 15, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    UDI-DI
    05415067024084
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PAIR OF EXPIRED ANCHORS WAS REPORTED TO ABBOTT. ALTHOUGH THE ANCHORS WERE PRESENT DURING THE OPERATION, ABBOTT ADVISED AGAINST THE IMPLANTATION OF THE ANCHORS, BUT THE EFFORT WAS UNSUCCESSFUL. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CONSISTENT WITH THE UNINTENTIONAL USE OF EXPIRED PRODUCT. ADDITIONALLY, THE DEVICE HISTORY RECORD OF THE DEVICE WAS REVIEWED TO CONFIRM THAT ALL MANUFACTURING STEPS WERE COMPLETED AND THERE WERE NO NON-CONFORMANCES NOTED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ACTIONS HAVE BEEN TAKEN TO PREVENT REOCCURRENCE VIA CAPA 132510. THE ANCHORS WERE ULTIMATELY REMOVED AND REPLACED WITH NEW ANCHORS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER 1627487-2022-05840. IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, TWO ANCHORS WERE FOUND TO HAVE PASSED THE EXPIRATION DATE. THE PHYSICIAN ELECTED TO USE THEM DESPITE KNOWLEDGE OF THE DATE AND IMPLANTED THE ANCHORS. THE ANCHORS WERE THEN EXPLANTED LATER THE SAME DAY DUE TO BEING ANTERIOR. NO CONSEQUENCES TO THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886821 SWIFT-LOCK ANCHOR SCS ANCHOR GZB ABBOTT MEDICAL 1192 7556558 05415067024084

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other