BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 18876269 · Received March 11, 2024

    Report

    Report Number
    1219602-2024-00448
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 30, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2127490, 2126084, 2136024 & 2133299, HOWEVER, IT IS UNKNOWN WHICH OF THE FOUR DEVICES CAUSED THE REPORTED EVENT. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE FOUR LOT NUMBERS REPORTED: 18-AUG-2026 (2127490), 29-JUL-2026 (2126084), 02-NOV-2026 (2136024) & 20-OCT-2026 (2133299). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE FOUR LOT NUMBERS REPORTED: 18-AUG-2023 (2127490), 29-JUL-2023 (2126084), 02-NOV-2023 (2136024) & 20-OCT-2023 (2133299).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). RESULTS OF INVESTIGATION: 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, 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. 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. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER IMPLANTING THE T1 IMPLANT OF THE FAST FIX 360, THE SURGEON TRIED TO FIRE THE SECOND IMPLANT AND IT DID NOT FIRE, REMAINING INSIDE THE DEVICE'S CANNULA. THE IMPLANT ONLY CAME OUT WHEN THE DEVICE WAS REMOVED FROM THE JOINT AND THE T2 IMPLANT WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464638 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown