MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CT; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A405

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/22/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a gastric surgery on (b)(6) 2022 and barbed suture was used in a box stitch.The knuckle of bowel got caught in the laparotomy fascia incision and the fascia was torn.Revision procedure was scheduled for (b)(6) 2022.Patient underwent laparoscopic hiatal hernia repair and gastric resection and bypass (rygb) and division of adhesions which turned into an open procedure.The surgeon opines that the barbed suture may have been the cause of the tearing of the tissue because they are too bendy at the tip.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®; active ingredient(s) ¿ triclosan; dosage form ¿ suture/solid/parenteral; strength ¿ = 2360 g/m.(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How many sxpp1a405 sutures were involved in the bowel getting caught in the fascia incision? did the patient undergo 2 procedures? gastric surgery on (b)(6) 2022 and gastric bypass on (b)(4) 2022 turned into open procedure? please explain.Date of index surgical procedure? the diagnosis and indication for the index surgical procedure? why was the procedure for laparoscopic hiatal hernia repair, gastric resection and bypass (rygb) and division of adhesions converted to an open procedure? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how and when was it diagnosed that the knuckle of bowel caught in laparotomy fascia incision from gastric surgery? please describe the surgical intervention required because the bowel got caught in the fascia incision.Please include dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? what symptoms did the patient experience following the index surgical procedure? onset date? how and when was the tear in the tissue requiring reoperation diagnosed? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? please provide the patient's weight and bmi at the time of index procedure.What is the patient's current status? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.What is the surgeon¿s experience with stratafix suture? related medwatch reports: 2210968-2022-06305.

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: i have asked if the surgeon could reply and have received nothing to date however i know she is currently in adelaide.Last time i tried chasing up information through her rooms also and that didn¿t get us any more information either.When i spoke to her a week or so ago she indicated that she felt the overloading of fluid put pressure on the tissue causing the issue however i totally understand it would be great if she could clarify things further.Once she is back next week i will try and get her assistance but i am not sure how much luck i will have.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15168430
• MDR Text Key: 297311742
• Report Number: 2210968-2022-06306
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227682
• UDI-Public: 10705031227682
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1A405
• Device Catalogue Number: SXPP1A405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female