BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 19310596 · Received May 14, 2024

    Report

    Report Number
    1219602-2024-01012
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    August 1, 2023
    Report Date
    July 5, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE 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 DEVICE INSTRUCTIONS FOR USE DOES NOTE THAT ¿IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE.¿ PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN NUMBER OF MENISCUS PROCEDURES, SEVERAL FAST-FIX 360 PRESENTED DIFFERENT MALFUNCTIONS; PROBLEMS WITH CANULA GETTING STUCK ON CONDYLE AND BREAKING OR BROKEN DELIVERY NEEDLE ON MINIMAL RESISTANCE WHEN ENTERING KNEE, OR PULLING ANCHORS FROM PUNCTURE SITE WITH MINIMAL EFFORT; HOWEVER NO INFORMATION WAS PROVIDED REGARDING HOW EACH SPECIFIC DEVICE FAILED. A TOTAL OF 3 DIFFERENT LOT NUMBERS (2105625, 2123986 AND 2111570) WERE REPORTED. HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHICH LOT NUMBER HAD EACH OF THESE FAILURES. THEREFORE, EACH LOT NUMBER PROVIDED WILL INCLUDE ALL THE PREVIOUS LISTED MALFUNCTIONS. WITH REPEATED ATTEMPTS AT SUTURING, THE MENISCUS WAS DESTROYED TO THE POINT THAT IT HAD TO BE REMOVED(MENISCECTOMY) OR FINISHED WITH SECOND OR THIRD STITCHING. SURGICAL DELAYS GREATER THAN 30 MINUTES WERE REPORTED. NO FURTHER INFORMATION OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649303 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2123986 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention