BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 10383263 · Received August 9, 2020

    Report

    Report Number
    1219602-2020-01213
    Event Type
    Injury
    Date Received
    August 9, 2020
    Date of Event
    July 16, 2020
    Report Date
    September 11, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 72202468 FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM, USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. THE INFORMATION PROVIDED STATES: ¿DURING A MENISCUS REPAIR, WHEN USING THE FAST-FIX, IT WAS FOUND THAT T1 AND T2 FELL OFF WHEN THE NEEDLE WAS IN THE PATIENT¿. VISUAL ASSESSMENT SHOWED THE NEEDLE HAS BEEN BENT. NO TS WERE RETURNED. THE DEPTH LIMITER WAS CUT TO SURGEON¿S DESIRED LENGTH. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: IMPROPER USE OF DEVICE. PER THE DEVICE IFU 10600499 UNDER WARNINGS ¿DO NOT BEND THE DELIVERY NEEDLE. THE FAST-FIX 360 DEVICES ARE MANUFACTURED WITH STRAIGHT OR CURVED DELIVERY NEEDLES. INTENTIONAL BENDING OF THE DELIVERY NEEDLE MAY MAKE IT DIFFICULT OR IMPOSSIBLE TO DELIVER THE T1 AND T2 IMPLANTS. IF THE DELIVERY NEEDLE HAS BEEN INADVERTENTLY BENT, OR IF RESISTANCE IS ENCOUNTERED DURING DEPLOYMENT, A NEW DELIVERY DEVICE MAY BE NEEDED. DO NOT PUSH THE DEPLOYMENT SLIDER TWICE OR THE SECOND IMPLANT WILL DEPLOY PREMATURELY¿. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE COMPLAINT RECORDS WAS PERFORMED AND INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR, WHEN USING THE FAST-FIX, IT WAS FOUND THAT T1 AND T2 FELL OFF WHEN THE NEEDLE WAS IN THE PATIENT. THE NEEDLE WAS NOT INSIDE THE MENISCUS. BOTH TS WERE REMOVED AND A BACK-UP DEVICE WAS AVAILABLE. IT IS UNKNOWN IF A DELAY OCCURRED AND NO OTHER COMPLICATIONS OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847483 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2040130 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention