BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 17261634 · Received July 5, 2023

    Report

    Report Number
    1219602-2023-01056
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 15, 2023
    Report Date
    January 28, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H10 H3, H6: THE REPORTED DEVICE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, ANOTHER DEVICE WAS RECEIVED. A VISUAL INSPECTION OF THIS DEVICE REVEALED A 72202468 BOX FOR LOT 2092804 WAS RECEIVED WITH THREE NON-COMPLAINT DEVICES IN IT. THE THREE DEVICES WERE ADDED AS CONCOMITANTS AND ARE NOT EVALUATED. AS CONFIRMED WITH THE REPORTER, THE COMPLAINT DEVICE, FAST-FIX 360, HAS BEEN DISPOSED OF BY THE SURGICAL TEAM AND COULDN¿T BE RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION 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 SECOND ACTUATION OF THE DEVICE OR EXCESSIVE RETRACTION OF THE DEVICE CAUSING T2 TO BE PULLED FROM THE NEEDLE. 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

    H2: ADDITIONAL INFORMATION IN A1, A2, A3, D9 AND H3. CORRECTION IN B5, E1 (INITIAL REPORTER) AND H6 (HEALTH EFFECT - IMPACT CODE).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE IMPLANTS T1 AND T2 OF THE FAST-FIX 360 WERE DEPLOYED SIMULTANEOUSLY. T2 WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE IMPLANTS T1 AND T2 OF THE FAST-FIX 360 WERE DEPLOYED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL 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
    1787323 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2092804 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female