BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24458275 · Received February 26, 2026

    Report

    Report Number
    1220246-2026-00961
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    July 1, 2021
    Report Date
    February 26, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    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 2021 BY ARTHROSCOPY, SPORTS MEDICINE, AND REHABILITATION TITLED "SUTURE TAPE AUGMENTATION ACL REPAIR, STABLE KNEE, AND FAVORABLE PROMS, BUT A RE-RUPTURE RATE OF 11% WITHIN 2 YEARS." THE STUDY REVIEWED TWENTY-FIVE (35) PATIENTS WHO UNDERWENT KNEE PROCEDURES USING ARTHREX SWIVELOCK TO TREAT ACL/PCL INSTABILITY. FOUR (4) PATIENTS HAD A RE-RUPTURE DURING THE TWENTY-FOUR (24) MONTH FOLLOW-UP PERIOD. REF: HEUSDENS, C. H. W., ET AL. (2021). "SUTURE TAPE AUGMENTATION ACL REPAIR, STABLE KNEE, AND FAVORABLE PROMS, BUT A RE-RUPTURE RATE OF 11% WITHIN 2 YEARS." KNEE SURG SPORTS TRAUMATOL ARTHROSC 29(11): 3706-3714.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119519 UNK BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other