BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 16530431 · Received March 13, 2023

    Report

    Report Number
    1219602-2023-00366
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    February 21, 2023
    Report Date
    October 10, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE INSERTION DEVICE WAS RETURNED IN THE PRET1 SETTING WITH NO SUTURE OR IMPLANTS RETURNED. A REVIEW OF THE CUSTOMER SUPPLIED IMAGE FINDS THE COMPLAINT DEVICE ON A SMITH+NEPHEW PRODUCT BOX WITH A LENGTH OF SUTURE BUT NO ANCHORS VISIBLE. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND IT CYCLES AS DESIGNED. 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. 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 APPLICATION OF EXCESSIVE FORCE OR CONTACT WITH ANOTHER SOURCE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, T2 OF THE FAST-FIX 360 COULD NOT BE DEPLOYED. T1 WAS REMOVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593194 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2080912 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention