BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 18640240 · Received February 5, 2024

    Report

    Report Number
    1219602-2024-00212
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    December 21, 2023
    Report Date
    February 29, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: 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 PRET2/POSTT1 SETTING WITH NO SUTURE OR IMPLANTS RETURNED. THERE IS BIOLOGICAL DEBRIS ON THE RETURNED DEVICE. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND IT CYCLES AS DESIGNED. 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, 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 UNINTENDED ACTUATION OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2123988 AND 2123985, HOWEVER, IT IS UNKNOWN WHICH OF THE TWO DEVICES CAUSED THE REPORTED EVENT. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE TWO LOTS REPORTED: 30-JUN-2026 (2123988) AND 29-JUN-2026 (2123985). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE TWO LOTS REPORTED: 30-JUN-2023 (2123988) AND 29-JUN-2023 (2123985).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE SECOND ANCHOR OF THE FAST-FIX 360 WAS NOT RELEASED AT THE DESIRED TIME, RESULTING IN THE ANCHOR BEING INCORRECTLY POSITIONED. THE ANCHOR WAS SUCCESSFULLY REMOVED FROM THE PATIENT. 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
    1622538 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown