MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

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

Patient Problems Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Pocket Erosion (2013); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2022

Event Type  Injury  

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.Component code: g07002 device not returned.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 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 will be sent.Did this patient require a reoperation due to the wound dehiscence and expulsion of thread fragments? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? 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 tissue dehisced? is it known how the wound dehisced? did the sutures barbs not engage in the tissue? did the suture pull out of the tissue? did the suture break? if so, where was the break noted (termination, middle, end)? were there any precipitating stress factors that led to the suture breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days).How was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.What symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product code and lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.Several weeks after the procedure, the patient experienced local skin reaction with scar disunity at different sites of the scars and expulsion of thread fragments.The suture would be at the origin of this reaction evoking an intolerance.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.Additional information was requested, and the following was obtained: what was the diagnosis and indication for the initial procedure? gonarthrosis.Total knee prosthesis.What was the initial approach for the initial procedure (open, laparoscopic or other)? opened what tissue was the suture used on? subcutaneous.What was the state of the tissues (normal, thin, calcified, fragile, diseased)? normal was the fixation tab pressed against the tissue at the start of suture use? no tab with this yarn.Were two reverse stitches performed on the incision prior to closure? yes.Do we know how the wound broke up? intolerance - allergy.Did the stitches not engage the tissue? no.Did the suture break? if yes, where was the break noted (termination, middle, end)? no.Were there any precipitating stressors that led to suture failure or tissue tearing? no.Could you provide us with more information on the surgery required for wound dehiscence, including date and results.? did the operating surgeon observe a defect or anomaly in the sutures before, during, after placing the sutures or during a re-operation? no.What is the physician's opinion of the etiology or contributing factors to this event? allergy - intolerance to yarn.What is the patient's current condition? i'm fine but disgraceful scar.

Manufacturer Narrative

(b)(4).Date sent to the fda: 4/7/2023.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: for the patient, a 2/0 stratafix thread and a 3/0 stratafix thread were used.For other questions, i cannot answer you.Related events reported via 2210968-2023-02526.

• Brand Name: STRATAFIX SYMMETRIC PDS
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 16291070
• MDR Text Key: 308711293
• Report Number: 2210968-2023-00786
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 03/23/2023
• Supplement Dates FDA Received: 02/24/2023; 04/07/2023
• 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