| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FIXT SUTURING DEVICE | SUTURING DEVICE | BARD SHANNON LIMITED -3005636544 | GDF | SD105 | HUYH1704 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-25 | 0 |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6). 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.
Patient 1
IT WAS REPORTED THAT THE FIXT DEVICE DID NOT CAPTURE THE BULLET DURING A SACROSPINAL FIXATION PROCEDURE. WHEN APPLYING THE SUTURE WITH THE FIXT DEVICE THROUGH THE SACROSPINAL LIGAMENT, THE BULLET WAS NOT CAUGHT AND THE SUTURE AND BULLET WERE LEFT BEHIND IN THE LIGAMENT. ATTEMPTS AT REMOVAL BY PULLING FAILED. A SECOND SUTURE WAS PLACED SUCCESSFULLY WITH THE SAME DEVICE. THE OR STAFF TESTS THE FIXT DEVICE TO CHECK IF THE WIRE IS TAKEN OVER PROPERLY AT THE BOTTOM PRIOR TO USE.
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "FOR USE WITH FIXT? SUTURES. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. THIS PRODUCT IS INTENDED FOR USE ONLY BY PHYSICIANS TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION. THE PHYSICIAN IS ADVISED TO CONSULT THE MEDICAL LITERATURE REGARDING TECHNIQUES, COMPLICATIONS, AND HAZARDS ASSOCIATED WITH THE INTENDED PROCEDURES. 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. NOTE: AS REQUIRED, THE DISTAL HEAD OF THE FIXT? SUTURING DEVICE MAY BE RINSED INTRAOPERATIVELY IN A BOWL OF STERILE SALINE TO REMOVE TISSUE DEBRIS." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE ...