BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER

    MDR report key: 19400826 · Received May 27, 2024

    Report

    Report Number
    1220246-2024-03996
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    May 4, 2023
    Report Date
    May 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867362871
    PMA / PMN Number
    K221396
    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. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-3636 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE SHAFT¿ TIP WAS BENT. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE, AS WELL AS THE BONE QUALITY ENCOUNTERED, WAS NOT PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS A USER ERROR. PER DFU-0054. G. PRECAUTIONS: 6. SUTURETAK AND FIBERTAK SUTURE ANCHORS ONLY: ANCHORS LOADED ON FLEXIBLE DRIVERS: THE DRILL GUIDE TIP MUST REMAIN IN CONTACT WITH THE BONE SURFACE DURING THE DRILLING AND IMPLANT IMPACTION STEPS OF THE PROCEDURE. FAILURE TO DO SO MAY RESULT IN DIFFICULTY SEATING THE IMPLANT TO ITS INTENDED DEPTH.

    Description of Event or Problem · 0

    IKT WAS REPORTED THAT DURING A BANKART SURGERY THE ANCHOR OF THE DEVICE DIDN`T RELEASE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 09-MAY-2023 IT WAS FURTHER CONFIRMED THAT THE ANCHOR HAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308629 SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER 14961761 00888867362871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown