BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAK

    MDR report key: 19444650 · Received June 2, 2024

    Report

    Report Number
    1220246-2024-04659
    Event Type
    Malfunction
    Date Received
    June 2, 2024
    Date of Event
    November 29, 2022
    Report Date
    June 2, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867290945
    PMA / PMN Number
    K130458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. COMPLAINT CONFIRMED. VISUAL EVALUATION REVEALS THAT THE SUTURES OF THE LOOPED KNOTLESS FIBERTEK IS TANGLE. ONE OF THE SUTURES TIPS IS FRAYED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE IMPLANT DID NOT TANGLE, AS IT IS STUCK TOGETHER. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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
    2125488 FIBERTAK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERTAK 14994624 00888867290945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown