BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED

    MDR report key: 16882566 · Received May 5, 2023

    Report

    Report Number
    1219602-2023-00665
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 17, 2023
    Report Date
    February 27, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    03596010597205
    PMA / PMN Number
    K072322
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2066133, 2082806 AND 2083824. HOWEVER, IT IS UNKNOWN WHICH OF THE THREE HAS THE REPORTED MALFUNCTION. D4, EXP. DATE: EXPIRATION DATES FOR THE THREE LOTS REPORTED: 12-JAN-2026 (LOT 2066133), 24-NOV-2026 (LOT 2082806) AND 07-DEC-2026 (LOT 2083824). H4, MGF. DATE: MANUFACTURING DATES FOR THE THREE LOTS REPORTED: 12-JAN-2021 (LOT 2066133), 24-NOV-2021 (LOT 2082806) AND 07-DEC-2021 (LOT 2083824).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE (B)(4).

    Additional Manufacturer Narrative · 0

    H10, H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE DEVICE WAS RETURNED IN ORIGINAL PACKAGING. THE T1, T2, AND SUTURE WERE NOT RETURNED. THE VARIABLE DEPTH STRAW HAS BEEN TRIMMED. BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED AS THE IMPLANTS HAVE ALREADY BEEN DEPLOYED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL EVALUATION STATES THAT THE IFU DOES WARN ¿IT IS THE HEALTHCARE PROFESSIONAL¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. ¿ THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE INVESTIGATION. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE AN UNINTENDED SECOND ACTUATION OF THE DEVICE OR EXCESSIVE RETRACTION OF THE DEVICE CAUSING T2 TO BE PULLED FROM THE NEEDLE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE TS OF THE ULTRA FAST CAME OUT DURING FIRST PASS. BOTH TS WERE LEFT INSIDE THE PATIENT'S JOINT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, ONE (1) ULTRA FAST FIX FAILED. THE SURGICAL TECHNIQUE WAS PERFORMED AND BOTH T IMPLANTS REMAINED IN THE CAPSULE, BUT WHEN THE SPECIALIST PULLED THE THREAD TO CLOSE THE LOOP, THE T2 IMPLANT WAS RELEASED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212370 ULTRA FAST-FIX ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72201491 UNKNOWN 03596010597205

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Other