BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-LESS T-ROPE W/DRV, SYN REPR, TI

    MDR report key: 17561545 · Received August 16, 2023

    Report

    Report Number
    1220246-2023-07517
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    August 7, 2018
    Report Date
    December 12, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    UDI-DI
    00888867281608
    PMA / PMN Number
    K043248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 FOR AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT TRIMALLEOLAR ANKLE FRACTURE WITH FIXATION OF THE DISTAL FIBULA FRACTURE, POSTERIOR MALLEOLUS FRACTURE, AND SYNDESMOTIC FIXATION. DURING THE (B)(6) 2018 SURGERY, THE FOLLOWING PRODUCTS WERE USED AND/OR IMPLANTED: AR-8740-52PTS QCKFIX SCRW,TI, CANN ST, CANC.,4.0X 52MM, LOT/SERIAL (B)(6), AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI, LOT/SERIAL (B)(6), AR-8933-20 LO-PRO SCRW,TI,3.0MMX 20MMCORT, LOT/SERIAL (B)(6), AR-8933V-12 3.0 X 12MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-14 3.0 X 14MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-16 3.0 X 16MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-18 3.0 X 18MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-20 3.0 X 20MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8935-12 LO-PRO SCRW,TI,3.5MMX 12MM, LOT/SERIAL (B)(6), AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6), AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6), AR-8935-26 LO-PRO SCRW,TI,3.5MMX 26MM, LOT/SERIAL (B)(6), AR-8943-01 GUIDE WIRE, TROCAR TIP, 1.35 MM, LOT/SERIAL (B)(6), AR-8943-02 DRILL BIT, CANNULATED, 2.6MM, LOT/SERIAL (B)(6), AR-8943-16 2.0MM DRILL BIT, CALIBRATED, LOT/SERIAL (B)(6), AR-8943-30 2.5MM DRILL BIT, LOT/SERIAL (B)(6), AR-8943-42 2.5MM DRILL BIT, CALIBRATED, LOT/SERIAL (B)(6), AR-9943BL-04 LOCKING DISTAL FIBULA PLATE, TI, LEFT, 4H, LOT/SERIAL (B)(6). AFTER SURGERY, IT WAS REPORTED THE PATIENT BEGAN TO EXPERIENCE ALLERGY LIKE SYMPTOMS AND ON (B)(6) 2018 A REVISION WAS PERFORMED BY THE SAME SURGEON AND THE ARTHREX DEVICES WERE REMOVED, INCLUDING THE AR-9943BL-04 (LOT 5261744) AND THE AR-8925T (LOT 10194892).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198230 K-LESS T-ROPE W/DRV, SYN REPR, TI WASHER, BOLT, NUT HTN ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, TI 10194892 00888867281608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other