BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410940 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00840
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    January 1, 2019
    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 IN 2019 BY THE JOURNAL OF CURRENT ORTHOPAEDIC PRACTICE TITLED ¿INCIDENCE OF GRAFT FAILURE WITH ACHILLES TENDON ALLOGRAFT COMBINED WITH RETROSCREWTM TIBIAL FIXATION IN PRIMARY ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION.¿ THE STUDY REVIEWED 50 PATIENTS AND IDENTIFIED ACL/PCL INSTABILITY WITH THE BIOABSORBABLE INTERFERENCE SCREWS AND TENODESIS SCREWS IN 6 PATIENTS DURING THE 2-YEAR FOLLOW-UP PERIOD. 4 PATIENTS EXPERIENCED AN ADDITIONAL SURGERY. REF: MANTELL M, FOX B, BAKER M, KAPPA J, HO A, PANDARINATH R. INCIDENCE OF GRAFT FAILURE WITH ACHILLES TENDON ALLOGRAFT COMBINED WITH RETROSCREWTM TIBIAL FIXATION IN PRIMARY ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. CURRENT ORTHOPAEDIC PRACTICE. 2019;30(3):263-268.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471571 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown