BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM

    MDR report key: 4914980 · Received July 15, 2015

    Report

    Report Number
    1219602-2015-00360
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 5, 2014
    Report Date
    July 14, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO (2) DEVICES WERE RECEIVED FOR EVALUATION. EACH DEVICE WAS RETURNED FULLY DEPLOYED. THE INSERTERS ACTUATE AND CYCLE PER DESIGN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR THE MANUFACTURED LOT(S) ON FILE. PER RESULTS OF THE INVESTIGATION, THERE IS INSUFFICIENT INFORMATION TO DETERMINE A ROOT CAUSE. AT THIS TIME, NO FURTHER INVESTIGATION IS WARRANTED. (B)(4).

    Description of Event or Problem · 1

    DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) RECONSTRUCTION PROCEDURE UTILIZING THE FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM, IT WAS REPORTED THAT AFTER DEPLOYING T1 IMPLANT, T2 WOULD NOT DEPLOY. THE SURGEON REMOVED THE INITIAL FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM AND PROCEEDED TO USE A SECONDARY DEVICE, WHICH ALSO WOULD NOT DEPLOY THE T2 IMPLANT. IT WAS REPORTED THAT NO IMPLANTS WERE LEFT INSIDE OF THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461212 FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50504977

    Patients

    Seq Age Sex Outcome Treatment
    1