BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 10242724 · Received July 7, 2020

    Report

    Report Number
    1219602-2020-00996
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    February 22, 2020
    Report Date
    July 7, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 72202468 FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM DEVICE INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. INSTRUCTIONS FOR USE CONTAINS RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. PLEASE NOTE: INADVERTENT TWISTING OR OVER FLEXING OF THE NEEDLE TRACK CAN AFFECT DEPLOYMENT AND MAY ENCOURAGE UNINTENDED RELEASE OR RETAINING OF ANCHORS. THE NEEDLE DID NOT DISPLAY ANY PERMANENT DAMAGE. T1 WAS RETURNED FREED FROM THE DELIVERY NEEDLE TIP. T2 AND BALANCE OF SUTURE WERE STILL WITHIN THE DELIVERY TRACK. SUTURE, ANCHORS AND NEEDLE HAD BIO MATTER ATTACHED. THE DEPTH LIMITER WAS ATTACHED AND WAS DISFIGURED. THIS SYMPTOMS ALIGNS WITH RESISTANCE FROM TISSUE AND WITH DIFFICULTY REACHING DESIRED ANCHORING LOCATION. THE ACTUATOR CYCLED OR ACTUATED DEPLOYING T2 AS EXPECTED. PER INSTRUCTION FOR USE: ¿DO NOT PUSH THE DEPLOYMENT SLIDER UNTIL THE NEEDLE IS FULLY PENETRATED THROUGH THE MENISCUS. DO NOT BEND THE DELIVERY NEEDLE. 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.¿ COMPLAINT HISTORY REVIEW INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION OR PRODUCT, PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE FAST FIX IMPLANTS CAME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT T1 WAS RETURNED FREED FROM THE DELIVERY NEEDLE TIP, T2 AND BALANCE OF SUTURE WERE STILL WITHIN THE DELIVERY TRACK. SUTURE, ANCHORS AND NEEDLE HAD BIO MATTER ATTACHED SO THIS MEANS THAT T2 WAS NOT ABLE TO BE DEPLOYED WHICH MAKES IT A REPORTABLE EVENT. 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
    706493 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 50800899 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention