BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 18821079 · Received March 1, 2024

    Report

    Report Number
    1220246-2024-01250
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    October 5, 2023
    Report Date
    June 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR APPLYING EXCESSIVE FORCE TO THE DEVICE DURING USE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER STABILISE SURGERY WITH AN ARTHREX FIBERTAK ANCHOR ON (B)(6) 2023 AND THE SURGERY WAS FINISHED WITHOUT FURTHER ISSUES. ON (B)(6) 2023THE PATIENT FELL AND WENT TO THE SURGERY FOR AN X-RAY PICTURE. ON THE PICTURE A SMALL LINEAR METALLIC FOREIGN BODY WAS NOTICED. ON (B)(6) 2024 A REVISION SURGERY WAS PERFORMED TO REMOVE THE FRAGMENT. THE REMOVAL WAS PERFORMED WITHOUT FURTHER ISSUES AND IT WAS FOUND THAT THE REMOVED OBJECT WAS THE INTRODUCER OF THE SUTURE ANCHOR WHICH APPARENTLY BROKE OFF DURING THE INITIAL PROCEDURE. *** UPDATE DW (B)(6) 2024: FURTHER INFORMATION WERE PROVIDED THAT THE SURGERY TOOK PLACE IN THE LEICESTER GENERAL HOSPITAL. NO FURTHER INFORMATION WERE MADE AVAILABLE BY THE CUSTOMER HOWEVER IT WAS FOUND IN THE SYSTEM THAT THE FOLLOWING DEVICES WERE DELIVERED TO THE CUSTOMER. AR-3600D, LOT: 15074722. AR-3603, LOT: 15070406. AR-302-1, LOT: 14971755.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212659 UNK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other