BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXT SUTURING DEVICE

    MDR report key: 5087204 · Received September 18, 2015

    Report

    Report Number
    1018233-2015-00351
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 17, 2015
    Manufacturer
    BARD SHANNON LIMITED -3005636544
    Product Code
    GDF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED SUTURING DEVICE. VISUAL INSPECTION DID NOT NOTE ANY OBVIOUS DEFECTS. FUNCTIONAL TESTING NOTED THAT THE UNIT CYCLED FREELY WITH NO ISSUES OBSERVED. THE UNIT WAS TESTED WITH AN IN-HOUSE IMPLANT/BULLET AND CAPTURED WITH NO PROBLEMS NOTED. THE UNIT FUNCTIONED PROPERLY. THE REPORTED EVENT COULD NOT BE REPLICATED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "DEVICE DESCRIPTION THE FIXT¿ SUTURING DEVICE IS A DEVICE DESIGNED AS AN AID FOR THE PLACEMENT OF SUTURES DURING PELVIC FLOOR SURGERY. INDICATIONS FOR USE: THE FIXT¿ SUTURING DEVICE IS INTENDED FOR USE IN GENERAL SUTURING APPLICATIONS TO ASSIST IN THE PLACEMENT OF SUTURE MATERIAL IN TISSUES AT THE OPERATIVE SITE. CONTRAINDICATIONS: THE FIXT¿ SUTURING DEVICE IS CONTRAINDICATED FOR PLACING SUTURES INTO OR THROUGH BONE. WARNINGS: THE INSTRUMENTATION ASSOCIATED WITH THE PLACEMENT OF SUTURE MATERIAL CAN CARRY AN INHERENT RISK OF BLEEDING. USE ONLY NEEDLES AND SUTURE SPECIFIED FOR USE WITH THE FIXT¿ SUTURING DEVICE. AFTER USE, THE PRODUCT AND ITS PACKAGING SHOULD BE TREATED AS A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS: THE FIXT¿ SUTURING DEVICE HAS NOT BEEN EVALUATED IN HUMAN SUBJECTS. BASED ON PHYSICIAN EXPERIENCE AND TRAINING, A THOROUGH ASSESSMENT OF EACH PATIENT SHOULD BE MADE TO DETERMINE THEIR SUITABILITY FOR THE PROCEDURE. CONSIDERATION SHOULD ALSO BE GIVEN TO THE ABILITY OF THE PATIENT TO TOLERATE THE SURGICAL PROCEDURE. THE FIXT¿ SUTURING DEVICE SHOULD ONLY BE USED WITH SIZE 0 FIXT¿ SUTURES WITH FX45 NEEDLES. WHEN LOADING AN FX45 NEEDLE INTO THE FIXT¿ SUTURING DEVICE, ENSURE THAT THE TIP OF THE NEEDLE DOES NOT PROTRUDE FROM THE NEEDLE DEPLOYMENT MECHANISM. DO NOT PLACE EXCESSIVE COUNTER-TRACTION ON THE SUTURE MATERIAL, AS THIS MAY RESULT IN INTERFERENCE WITH THE DEPLOYMENT MECHANISM AND MAY DAMAGE THE SUTURE MATERIAL. ONCE THE SUTURING MECHANISM HAS BEEN ACTIVATED, CONTINUE DEPRESSING THE HANDLE UNTIL THE NEEDLE HAS BEEN FULLY DEPLOYED. STOPPING MID-STITCH MAY DISLODGE THE NEEDLE FROM THE DEPLOYMENT MECHANISM AND CAUSE AN INADEQUATE TRANSFER OF THE NEEDLE TO THE CAPTURE MECHANISM. ONCE THE SUTURING MECHANISM HAS BEEN ACTIVATED, DO NOT ROTATE OR TORQUE THE FIXT¿ SUTURING DEVICE, AS THIS MAY RESULT IN PATIENT INJURY. THE FIXT¿ SUTURING DEVICE IS PROVIDED STERILE INSIDE A HOLDING TRAY WITHIN AN OUTER BOX. THE HOLDING TRAY IS NOT STERILE AND MAY NOT BE PLACED IN THE STERILE FIELD. TRANSFER THE DEVICE TO THE STERILE FIELD USING ASEPTIC TECHNIQUES. CHECK THE INTEGRITY OF THE PACKAGING BEFORE USE. DO NOT USE THE DEVICE IF THE PACKAGING IS OPENED OR DAMAGED. AS FOR ANY STERILE SURGICAL INSTRUMENTATION, IT IS RECOMMENDED TO OPEN THE TRAY AT THE TIME OF USE. THE FIXT¿ SUTURING DEVICE IS INTENDED AS A SINGLE-PATIENT USE DEVICE. DO NOT RE-STERILIZE ANY PORTION OF THE FIXT¿ SUTURING DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. ADVERSE EVENTS: POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PROPER USAGE OF THE FIXT¿ SUTURING DEVICE MAY INCLUDE, BUT ARE NOT LIMITED TO: BLEEDING, HEMATOMA, INFECTION, INJURY TO INTERNAL VESSELS AND NERVES, INJURY TO INTERNAL ORGANS AND TISSUE INCLUDING PERFORATION AND OCCLUSION, INFLAMMATORY REACTION TO SUTURE MATERIAL OR THE TRAUMA OF BEING SUTURED. DIRECTIONS FOR USE: CONNECT THE STAINLESS STEEL NEEDLE POINT OF THE APPROPRIATE SUTURE INTO THE NEEDLE DEPLOYMENT MECHANISM. SUPPORT THE SUTURE THROUGHOUT THE PROCEDURE. POSITION THE DISTAL HEAD OF THE DEVICE IN THE DESIRED LOCATION FOR SUTURING. WHILE APPLYING DIGITAL PRESSURE AGAINST THE RIDGES ON THE HEAD OF THE DEVICE, COMPLETELY DEPRESS THE TRIGGER MECHANISM TO DELIVER THE SUTURE THROUGH THE DESIRED TISSUES. THE DEVICE WILL CAPTURE THE NEEDLE POINT ON THE OTHER SIDE OF THE TISSUES. RELEASE THE TRIGGER MECHANISM TO ALLOW THE NEEDLE DEPLOYMENT MECHANISM TO RETURN TO ITS ORIGINAL POSITION. AS THE DEVICE IS WITHDRAWN FROM THE SURGICAL SITE, THE CAPTURED SUTURE WILL BE WITHDRAWN ALONG WITH IT. REMOVE THE NEEDLE POINT FROM THE CATCHMENT MECHANISM BY DEPRESSING THE BUTTON ON THE UNDERSIDE OF THE DEVICE HEAD. SUTURE KNOTS MAY NOW BE TIED DOWN TO COMPLETE THE PROCEDURE. ENSURE THAT NEEDLE TIPS ARE REMOVED AND DISPOSED OF IN APPROPRIATE SHARPS CONTAINERS." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SACROSPINAL FIXATION PROCEDURE, THE FIRST SUTURE WENT FINE, BUT THE SECOND SUTURE FAILED. THE BULLET WAS NOT CAUGHT AND THE PLUG OF THE SUTURE WAS LEFT BEHIND IN THE PATIENT. A NEW FIXT DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PER ADDITIONAL INFORMATION RECEIVED, THE BULLET BROKE OFF OF THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619287 FIXT SUTURING DEVICE SUTURING DEVICE GDF BARD SHANNON LIMITED -3005636544 HUYL0417

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention