BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP SWVLK 3.5X 15.8MM

    MDR report key: 19153030 · Received April 22, 2024

    Report

    Report Number
    1220246-2024-02203
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    August 16, 2022
    Report Date
    April 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867026957
    PMA / PMN Number
    K101823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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 MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022 BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325BCC SWIVELLOCK ANCHOR BACKED OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241797 BIO-COMP SWVLK 3.5X 15.8MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM 14948208 00888867026957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown