BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTR ANCHOR ALL-SUTR 1.4MM STRL KIT

    MDR report key: 23682355 · Received December 1, 2025

    Report

    Report Number
    3008650117-2025-00014
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 5, 2025
    Report Date
    June 1, 2026
    Manufacturer
    PARAGON 28
    Product Code
    GAT
    UDI-DI
    00889795114280
    PMA / PMN Number
    K211002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: SUTR ANCHOR ALL-SUTR 1.4MM STRL KIT CAT #: P44-210-0014-SK LOT #: 5010540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE 2 INSTRUMENT FRACTURED, AND THE DEBRIS REMAINS IN THE PATIENT WITH NO KNOWN IMPACT OR CONSEQUENCE REPORTED AT THE TIME OF THE EVENT. NO ADDITIONAL PATIENT TREATMENT BEYOND INTRAOPERATIVE IMAGING AND RETRIEVAL ATTEMPTS WAS REPORTED. THERE WERE NO KNOWN COMPLICATIONS REPORTED AT THE TIME, AND NO IMMEDIATE REVISION WAS REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149523 SUTR ANCHOR ALL-SUTR 1.4MM STRL KIT SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT PARAGON 28 5010540 00889795114280

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other SEE H11 NARRATIVE