BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4-0 FIBERLOOP, 12 INCHES WITH NEEDLE

    MDR report key: 18002192 · Received October 25, 2023

    Report

    Report Number
    1220246-2023-08355
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 29, 2023
    Report Date
    November 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041592
    PMA / PMN Number
    K122374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED AR-7229-12 SERIAL/BATCH NUMBER 27512 WAS RECEIVED FOR EVALUATION. IT ALSO RECEIVED ONE SEALED BOX THAT CONTAINED 12 DEVICES AND ONE OPEN BOX WITH 10 SEALED AR-7229-12 SERIAL/BATCH NUMBER 27512. VISUAL EVALUATION OF THE NEEDLE UNDER THE MAGNIFIER FOUND THAT THE POINT OF THE NEEDLE WAS SHARP; NO ISSUES WERE OBSERVED ON THE BODY OF THE NEEDLE. INSPECTION OF THE SUTURE FOUND NO ISSUES. NO PROBLEM FOUND. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS A USE ERROR.

    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

    IT WAS REPORTED THAT, DURING A FLEXOR TENDON SUTURE SURGERY, IT WAS FOUND THAT THE NEEDLE WAS DULL. 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. UPDATE, KHE, 18-OCT-2023: THE FOLLOWING DEVICES WERE RECEIVED: 1 UNOPENED PACKAGE, 1 OPENED PACKAGE WITH 9 ORIGINAL PACKED NEEDLES, 2 UNPACKED NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047525 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE 27512 00888867041592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown