BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNOTLESS T-ROPE SYN-DESMOSIS REPR TI

    MDR report key: 8526634 · Received April 18, 2019

    Report

    Report Number
    1220246-2019-01047
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    November 6, 2017
    Report Date
    May 8, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    UDI-DI
    00888867049086
    PMA / PMN Number
    K043248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED 4/24/2019. THE EVENT DESCRIPTION HAS BEEN UPDATED TO REFLECT THIS ADDITIONAL INFORMATION. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES. EVALUATION SHOWS THE DEVICES WERE DAMAGED, WHICH MOST LIKELY OCCURRED DURING INSERTION AND/OR EXPLANTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT AN ANKLE FRACTURE PROCEDURE WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8943C-10 / LOT: 1338539 X1, AR-8835-20 / LOT: 10016008 X1, AR-8835L-14 / LOT: 141751 X1, AR-8835L-16 / LOT: 10003529 X3, AR-8835L-18 / LOT: 1382955 X3, AR-8926T / LOT: 17469 X1. PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2019 FOR AN UNKNOWN REASON. ALL DEVICES LISTED ABOVE WERE EXPLANTED. ADDITIONAL INFORMATION PROVIDED 4/24/2019: THE SECOND SURGERY WAS CONFIRMED AND THE DEVICES LISTED WERE EXPLANTED. PATIENT WAS OPERATED AND TITANIUM IMPLANTS WERE PLACED TO REPLACE THE EXPLANTED STEEL IMPLANTS. IT WAS REPORTED THAT THE PRODUCTS WERE WITHDRAWN IN THE SECOND SURGERY FOR SAFETY AND TO AVOID METALLOSIS. NO FURTHER EXPLANATION WAS PROVIDED AS TO ANY ADDITIONAL REASON FOR THE SECOND SURGERY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT AN ANKLE FRACTURE PROCEDURE WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8943C-10 / LOT: 1338539 X1; AR-8835-20 / LOT: 10016008 X1; AR-8835L-14 / LOT: 141751 X1; AR-8835L-16 / LOT: 10003529 X3; AR-8835L-18 / LOT: 1382955 X3; AR-8926T / LOT: 17469 X1. PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2019 FOR AN UNKNOWN REASON. ALL DEVICES LISTED ABOVE WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323272 KNOTLESS T-ROPE SYN-DESMOSIS REPR TI WASHER, BOLT NUT HTN ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR TI 17469 00888867049086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other