BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 16308508 · Received February 6, 2023

    Report

    Report Number
    1219602-2023-00147
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    December 27, 2022
    Report Date
    August 15, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE DEVICE IS NOT IN ITS ORIGINAL PACKAGING. THE INSERTION DEVICE WAS RETURNED IN THE PRET1 SETTING WITH THE SUTURE AND IMPLANTS RETURNED IN THE CHANNEL, READY TO DEPLOY, THERE WAS A SMALL TAIL OF SUTURE VISIBLE FROM BELOW THE WHITE DEPTH GUIDE. AN ASSESSMENT OF MATERIAL CHARACTERISTICS WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THAT BASED ON THE CONDITION OF THE PRODUCT MATERIAL FOUND DURING VISUAL INSPECTION, NO FRACTURE OF THE IMPLANT COULD BE CONFIRMED. ADDITIONAL MATERIAL TESTING IS NOT REQUIRED. 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. 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 REVIEW OF THE MATERIAL SPECIFICATIONS FOUND A MATERIAL CERTIFICATION OF ANALYSIS IS REQUIRED WITH EACH LOT. 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 DAMAGE CAUSED BY SHARP INSTRUMENTS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, WHEN A FAST FIX WAS OPENED, THE THREAD WAS FOUND TO BE BROKEN. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494514 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2092802 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown