BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24469554 · Received February 27, 2026

    Report

    Report Number
    1220246-2026-01051
    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 ELSEVIER INC. TITLED ¿MID-TERM OUTCOMES OF AUTOLOGUS BRIDGING OF ROTATOR CUFF TEARS WITH AN AUTOLOGOUS TENDON PATCH (TEAR PATCH).¿ THE STUDY REVIEWED FORTY-FOUR (44) PATIENTS WHO UNDERWENT SHOULDER PROCEDURES FOR ROTATOR CUFF LESION USING ARTHREX CORKSCREW DEVICES. FOUR (4) PATIENTS WERE DOCUMENTED TO HAVE EXPERIENCED INFECTION RESULTING IN A REVISION SURGERY AND FIVE (5) WERE DOCUMENTED TO HAVE COMPLETE FAILURE OF THE TENDON PATCH DURING THE TWENTY-FOUR (24) MONTH FOLLOW-UP PERIOD. REF: ALBERS, S., ET AL. (2023). "MID-TERM OUTCOMES OF AUTOLOGUS BRIDGING OF ROTATOR CUFF TEARS WITH AN AUTOLOGOUS TENDON PATCH (TEAR PATCH)." J SHOULDER ELBOW SURG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527639 UNK BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other