BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24468698 · Received February 27, 2026

    Report

    Report Number
    1220246-2026-01028
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    July 1, 2024
    Report Date
    February 27, 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 28-JAN-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2024 BY ARTHROSCOPY, SPORTS MEDICINE, AND REHABILITATION TITLED. "CLINICAL, RADIOLOGICAL AND DYNAMIC CT RESULTS OF SCAPHOLUNATE INTERCARPAL LIGAMENTOPLASTY FOR SCAPHOLUNATE DISSOCIATION." THE STUDY REVIEWED ONE HUNDRED TWENTY-NINE (29) PATIENTS WHO UNDERWENT HAND AND WRIST PROCEDURES USING ARTHREX CORKSCREW TO TREAT SCAPHOLUNATE INSTABILITY. ONE (1) PATIENT HAD COMPLEX REGIONAL PAIN SYNDROME DURING THE SIXTY-ONE (61) MONTH FOLLOW-UP PERIOD. REF: ATHLANI, L., ET AL. (2024). "CLINICAL, RADIOLOGICAL AND DYNAMIC CT RESULTS OF SCAPHOLUNATE INTERCARPAL LIGAMENTOPLASTY FOR SCAPHOLUNATE DISSOCIATION." HAND SURG REHABIL 43(5): 101762.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528161 UNK BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other