BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP 2.6 MM KNOTLESS FIBERTAK ANCHOR

    MDR report key: 18787409 · Received February 27, 2024

    Report

    Report Number
    1220246-2024-01141
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 5, 2024
    Report Date
    December 9, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867341906
    PMA / PMN Number
    K232742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, H3, H6 COMPLAINT IS CONFIRMED. ONE UNPACKAGED, AR-3641SP, BATCH 5018496, SUTURE ASSEMBLY WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE TIP WAS BROKEN AND BENT. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.

    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. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    *** UPDATE DW (B)(6) 2024: IT WAS FOUND THAT THE DRIVER OF THE DEVICE AND NOT THE ANCHOR WAS BENT. IT WAS FURTHER NOTICED THAT A SMALL FRAGMENT OF THE DRIVER HAS BROKEN OFF. *** UPDATE DW (B)(6) 2024: FURTHER INFORMATION WAS PROVIDED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR SEVERELY BENT DURING INSERTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539310 SP 2.6 MM KNOTLESS FIBERTAK ANCHOR ARTHROSCOPE AND ACCESSORIES MBI ARTHREX, INC. SP 2.6 MM KNOTLESS FIBERTAK ANCHOR 15018496 00888867341906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown