BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROF SCRW,SS 4.0X 35MMCANN LNG THD

    MDR report key: 9756726 · Received February 26, 2020

    Report

    Report Number
    1220246-2020-01728
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    May 1, 2015
    Report Date
    February 26, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867048164
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    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 A PATIENT HAD VARIOUS ARTHREX SCREWS IMPLANTED DURING AN ANKLE FIXATION PROCEDURE. THE (B)(6) OFFICE CONTACTED ARTHREX REQUESTING MATERIAL COMPOSITIONS OF THE IMPLANTED PRODUCT AS THEY ARE CONCERNED THAT THE PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE METALS IN THE SCREWS. THE FOLLOWING ARTHREX PART NUMBERS WERE PROVIDED BY THE ALLERGIST; AR-8840-16, AR-8840CL-35, AR-8840CL-40. THE ALLERGIST IS REQUESTING THE MATERIAL COMPOSITIONS OF THE SCREWS TO TEST THE PATIENT FOR THE APPROPRIATE METALS. AT THIS TIME NO ADDITIONAL DETAILS OR INFORMATION HAS BEEN PROVIDED TO ARTHREX REGARDING THE TYPE OF SYMPTOMS THE PATIENT IS EXPERIENCING, AND/OR THE SPECIFIC CASE DETAILS. ADDITIONAL INFORMATION RECEIVED ON 02/13/2020: THE ALLERGIST REPORTED THE ORIGINAL PROCEDURE TOOK PLACE IN (B)(6) 2014. THE PATIENT WAS EXPERIENCING SWELLING AND PAIN, AND A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2015. THE IMPLANTED SCREWS WERE REMOVED DURING THE REVISION PROCEDURE. THE ALLERGIST REPORTED THE PATIENT IS CURRENTLY EXPERIENCING ANKLE PAIN AND SWELLING YEARS AFTER HAVING THE SCREWS COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217456 LOW PROF SCRW,SS 4.0X 35MMCANN LNG THD SCREW, FIXATION, BONE HWC ARTHREX, INC. LOW PROF SCRW,SS 4.0X 35MMCANN LNG THD UNK 00888867048164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other