BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 15312442 · Received August 29, 2022

    Report

    Report Number
    1219602-2022-01257
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 7, 2022
    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).

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A VISUAL EVALUATION OF THE DEVICE SHOWED IT WAS RETURNED IN THE ORIGINAL BOX WITH THE BATCH NUMBER OF THE COMPLAINT ON THE LABEL. THE T1 AND T2 WERE NOT RETURNED. PART OF THE SUTURE WAS RETURNED. ONE END OF THE SUTURE IS FRAYED. THE ACTUATOR IS IN THE PRE-T1/POST-T2 POSITION. THERE IS BIO DEBRIS IN THE NEEDLE. A FUNCTIONAL EVALUATION OF THE DEVICE SHOWED IT CYCLED AS INTENDED. AN EVALUATION OF THE CUSTOMER PROVIDED IMAGE SHOWS A DEVICE LAYING ON A SHIPPING POUCH WITH A DIFFERENT BATCH NUMBER, (2080891), THAN THE COMPLAINT. THE T1/T2/SUTURE ARE NOT ON THE NEEDLE. BASED ON THE CONDITION OF THE PRODUCT MATERIAL FOUND DURING VISUAL INSPECTION, 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 SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS 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 WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE BREAKAGE OF THE SUTURE IF THERE IS 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 AN ARTHROSCOPY, AFTER T1 OF THE FAST-FIX 360 WAS DEPLOYED, THE SUTURE BROKE. T1 WAS REMOVED FROM THE PATIENT BY TWEEZERS. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594562 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2080895 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention