BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410643 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00751
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    February 1, 2016
    Report Date
    February 22, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON FEBRUARY 2016 BY THE ARCH ORTHOP TRAUMA SURGICAL JOURNAL ¿TREATMENT STRATEGIES FOR PARTIAL CHRONIC INSTABILITY OF THE DISTAL SYNDESMOSIS: AN ARTHROSCOPIC GRADING SCALE AND OPERATIVE STAGING CONCEPT.¿ THE STUDY REVIEWED 32 PATIENTS AND IDENTIFIED ANKLE INSTABILITY DUE TO A SUTURE GRANULOMA WITH BIOABSORBABLE INTERFERENCE SCREWS IN 2PATIENTS DURING THE 1.5-YEAR FOLLOW-UP PERIOD. REF: COLCUC C, FISCHER S, COLCUC S, ET AL. TREATMENT STRATEGIES FOR PARTIAL CHRONIC INSTABILITY OF THE DISTAL SYNDESMOSIS: AN ARTHROSCOPIC GRADING SCALE AND OPERATIVE STAGING CONCEPT. ARCH ORTHOP TRAUMA SURG. FEB 2016;136(2):157-63. DOI:10.1007/S00402-015-2371-Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471988 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown