BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL SYS,CMC MINI T-ROPE,1.1 MM

    MDR report key: 18956189 · Received March 21, 2024

    Report

    Report Number
    1220246-2024-01626
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 25, 2021
    Report Date
    March 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    UDI-DI
    00888867048966
    PMA / PMN Number
    K140328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    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. ONE UNPACKAGED C0669-01 SUTURE PASSING K-WIRE AND ONE C5077-01 SUTURE PASSING GUIDE PIN WERE RETURNED FROM AN AR-8919DS (NO BATCH IDENTIFIERS PRESENT). ANALYSIS WITH CALIBRATED RULER ID: 651 DETERMINED THAT BOTH RETURNED COMPONENTS FELL WITHIN EACH OF THEIR RESPECTIVE LENGTH DIMENSIONAL TOLERANCES, AND NO BREAKAGE WAS NOTED ACROSS EITHER COMPONENT. THE PROXIMAL END OF THE SUTURE PASSING GUIDE PIN APPEARED TO BE BOTH CRIMPED AND SLIGHTLY WARPED, AND NO NITINOL WIRE LOOP WAS PRESENT. THE NITINOL WIRE LOOP WAS NOT RETURNED FOR INSPECTION. BASED ON THE OBSERVED CONDITION OF THE GUIDE PIN, THIS EVENT IS MOST LIKELY THE RESULT OF USER APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOOP OF THE DEVICE CAME LOOSE DURING INSERTION. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT 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 AVOE 31-MAR-2021: IT WAS CONFIRMED THAT THE DEVICE TORE OUTSIDE OF THE PATIENT AND NOTHING BROKE INSIDE OF THE PATIENT. NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317139 IMPL SYS,CMC MINI T-ROPE,1.1 MM WASHER, BOLT, NUT HTN ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM 10298495 00888867048966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown