BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 16637394 · Received March 29, 2023

    Report

    Report Number
    1219602-2023-00455
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 2, 2023
    Report Date
    July 5, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6: HEALTH EFFECT - IMPACT CODE.

    Additional Manufacturer Narrative · 0

    H10: H2: ADDITIONAL INFORMATION: B5 AND H6: HEALTH EFFECT - CLINICAL AND IMPACT CODE. H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE INSERTION DEVICE WAS RETURNED IN THE PRET2/POSTT1 SETTING WITH NO SUTURE OR IMPLANTS RETURNED. A FUNCTIONAL EVALUATION FINDS IT CYCLES AS DESIGNED. 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. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. FACTOR THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE A FAILURE TO FULLY ACTUATE THE DEVICE BEHIND THE MENISCUS DURING IMPLANTATION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE T2 OF THE FAST FIX DEVICE FELL OFF THE MENISCUS. THE T2 OF THE DEVICE WAS REMOVED FROM THE PATIENT USING TWEEZERS AND T1 WAS LEFT SECURE IN THE MENISCUS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON SIGNIFICANT DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE T2 OF THE FAST FIX DEVICE FELL OFF THE MENISCUS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON SIGNIFICANT DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960044 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2080891 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other