MAUDE Adverse Event Report: ETHICON INC. STRATAFIX UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

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

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-00153.Citation: china tissue engineering research, 2020, 24 (10): 1585-1590.Https://doi.Org/10.3969/j.Issn.2095-4344.2231.

Event Description

Title: a randomized controlled trial of knotless barbed suture stitching deep fascia in posterior lumbar decompression and fusion.This prospective randomized controlled trial was to explore whether knotless barbed suture has advantages in shortening the suturing time and reducing incision complication in posterior lumbar fusion.A total of 62 patients with lumbar degenerative diseases admitted to (b)(6) hospital from january to december 2018 were selected and underwent posterior lumbar spine.The patients were randomly divided into trial group (n=33, 10 male and 23 female; mean age of 65.7 ± 2.1 years) using knotless barbed suture [1-0 stratafix symmetric, ethicon limited]) and control group (n=29, 13 male and 16 female; mean age of 66.2 ± 3.7 years) using absorbable suture [1-0 vicryl plus, ethicon llc]) to suture deep lumbar fascia.In both groups, 1-0 vicryl plus antibacterial absorbable suture "figure-of-eight" suture technique was used to make the muscles on both sides of spinous process gathered near the midline.2-0 antibacterial vicryl suture was used for continuous suture of subcutaneous tissue, and 4-0 antibacterial vicryl suture was used for continuous intradermal suture of skin.Reported complications include: in the test group, positive leak test (n=2), skin edge erythema (n=1) and skin edge induration (n=1).In the control group, positive leak test (n=7), skin edge erythema (n=2), skin edge induration (n=1), wound infection (n=1), incision dehiscence (n=1), and incision oozing (n=2).In conclusion, the application of knot-free barbed suture in posterior lumbar open fusion was safe and effective.The use of this suture material could reduce the intraoperative deep fascia suture time and postoperative incision complications.It is worthy of being widely popularized.

• Brand Name: STRATAFIX UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16117516
• MDR Text Key: 306852257
• Report Number: 2210968-2023-00154
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2022
• 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