BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KL 1.8 FIBERTAK, SHOULDER

    MDR report key: 17939750 · Received October 16, 2023

    Report

    Report Number
    1220246-2023-08211
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 21, 2023
    Report Date
    June 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867362871
    PMA / PMN Number
    K221396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. THE COMPLAINT ALLEGATION IS CONFIRMED. TWO OPENED AR-3636 / BATCH 15063402 WERE RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE INSERTER TIPS OF THE DEVICES ARE BROKEN OFF. ADDITIONAL EVALUATION INCLUDED MEASURING THE THICKNESS OF BOTH WITH BLADE MICROMETER - 1007809. THE FIRST SET, CONSISTING OF A SMALLER BROKEN PIECE (PIECE A), AS WELL AS THE LARGER PIECE ATTACHED TO THE HANDLE (PIECE A). PER DRAWING C15947- REVISION 2, BOTH PIECES OF THE TIP ARE WITHIN TOLERANCE OF THE DRAWING'S SPECIFICATIONS. PIECE-A HAD A THICKNESS OF .024 AND WAS EXPECTED TO BE .024 ± .002. THUS, PASSING WITHIN TOLERANCE. PIECE-A HAD A THICKNESS OF .015 AND WAS EXPECTED TO BE .015 ± .001 - ALSO PASSING WITHIN TOLERANCE. THE SECOND SET, CONSISTING OF A SMALLER BROKEN PIECE (PIECE B), AS WELL AS THE LARGER PIECE ATTACHED TO THE HANDLE (PIECE B). PER DRAWING C15947- REVISION 2, BOTH PIECES OF THE TIP ARE WITHIN TOLERANCE OF THE DRAWING'S SPECIFICATIONS. PIECE-B HAD A THICKNESS OF .022 AND WAS EXPECTED TO BE .024 ± .002. THUS, PASSING WITHIN TOLERANCE. PIECE-B HAD A THICKNESS OF .014 AND WAS EXPECTED TO BE .015 ± .001 - ALSO PASSING WITHIN TOLERANCE. PER CUSTOMER, THE QUALITY OF THE BONE WAS HARD. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO PRYING/LEVERAGING THE DEVICE DURING INSERTION. THE CAUSE REMAINS ERROR USE. PER DFU-0054-EOR2, PRECAUTION #6: 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. FURTHERMORE, DFU-0404-SUB-EOR0, WARNS TO AVOID EXCESSIVE IMPACTION AS THIS COULD LEAD TO INSERTER DAMAGE AND/OR BREAKAGE. IF INSERTION RESISTANCE IS ENCOUNTERED, DO NOT IMPACT HARDER. REPLACE THE IMPLANT AND REPEAT THE DRILLING/INSERTION PROCESS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT (3) AR-3636 KNOTLESS FIBERTAK TIP BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED USING A 2.9 PUSHLOCKS. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY WITH LABRAL REPAIR PROCEDURE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705059 KL 1.8 FIBERTAK, SHOULDER NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. KL 1.8 FIBERTAK, SHOULDER 15063402 00888867362871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown