BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410869 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00807
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    November 1, 2022
    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 NOVEMBER 2022 BY THE AMERICAN JOURNAL OF SPORTS MEDICINE ¿THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE, PATIENT ACCEPTABLE SYMPTOM STATE, AND CLINICAL OUTCOMES OF ANTERIOR CRUCIATE LIGAMENT REPAIR VERSUS RECONSTRUCTION: A MATCHED-PAIR ANALYSIS FROM THE SANTI STUDY GROUP.¿ THE STUDY REVIEWED 75 PATIENTS AND IDENTIFIED ACL/PCL INSTABILITY WITH BIOABSORBABLE INTERFERENCE SCREWS IN 33 PATIENTS DURING THE 3-YEAR FOLLOW-UP PERIOD. 8 PATIENTS EXPERIENCED CYCLOPS SYNDROME (ROM). REF: FERREIRA A, SAITHNA A, CARROZZO A, ET AL. THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE, PATIENT ACCEPTABLE SYMPTOM STATE, AND CLINICAL OUTCOMES OF ANTERIOR CRUCIATE LIGAMENT REPAIR VERSUS RECONSTRUCTION: A MATCHED-PAIR ANALYSIS FROM THE SANTI STUDY GROUP. AM J SPORTS MED. NOV 2022;50(13):3522-3532. DOI:10.1177/03635465221126171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471522 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown