BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410640 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00748
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    December 1, 2023
    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 DECEMBER 2023 BY THE ORTHOP TRAUMATOL SURG RES TITLED ¿LONG-TERM GRAFT RUPTURE RATES AFTER COMBINED ACL AND ANTEROLATERAL LIGAMENT RECONSTRUCTION VERSUS ISOLATED ACL RECONSTRUCTION: A MATCHED-PAIR ANALYSIS FROM THE SANTI STUDY GROUP.¿ THE STUDY REVIEWED 29 PATIENTS AND IDENTIFIED PATELLAR INSTABILITY RESULTING IN DISABLING PAIN WITH BIOABSORBABLE INTERFERENCE SCREWS AND TENODESIS SCREWS IN 1 PATIENT DURING THE 12-YEAR FOLLOW-UP PERIOD. REF: ZAMPIERI A, GIRARDIN C, HOCQUET B, ET AL. PATELLAR DISLOCATION RECURRENCE AFTER PEDIATRIC MPFL RECONSTRUCTION: BONE TUNNELS AND SOFT TISSUE VERSUS SUTURE ANCHORS AND INTERFERENCE SCREW. ORTHOP TRAUMATOL SURG RES. DEC 2023;109(8):103515. DOI:10.1016/J.OTSR.2022.103515.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475498 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown