MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI 18IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A101

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868)

Event Date 10/26/2022

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.(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received as 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.Date and name of index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used/location of suture placement? 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? what was the tissue condition (normal, thin, calcified, fragile, diseased)? 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.Please describe the appearance of the suture during the second procedure.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).Please provide the onset date/time of the reaction from the initial procedure.Please describe any medical intervention required to treat the patient condition including medication name and results.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.Are there any photos available? 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? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.Related events reported via 2210968-2022-09121.

Event Description

It was reported that a patient underwent a bilateral total knee arthroplasty on (b)(6) 2022 and a barbed suture was used for subcutaneous dermal suture.Post-op, two months later, the patient experienced a symptom that seemed to be a foreign substance reaction.The wound became white and dehiscent.The suture broke and dehiscence occurred.Therefore, removal of the suture and epidermal re-suturing was performed with nylon.The area where the suture was removed was recovering.The patient is being followed up on an outpatient basis and is doing well.It was opined that since the symptoms improved after removal, there is a possibility that the device was the cause of the event.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: date and name of index surgical procedure?:(b)(6)2022.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)?:no further information is available.On what tissue was the suture used/location of suture placement?:subcutaneous dermis was the fixation tab seated against the tissue at the initiation of suture use during the index procedure?:no further information is available.Were two reverse stitches performed across the incision prior to closure?:unknown what tissue dehisced?:epidermis, dermis what was the tissue condition (normal, thin, calcified, fragile, diseased)?:dr.Said the patient had no specific medical history.Onset date/time of dehiscence? (# post op days):procedure date aug 23, dehiscence on oct 26.How was the dehiscence managed? :epidermal suturing was performed with nylon after the suture was removed.Please describe any surgical intervention required for the wound dehiscence including date and findings.:unknown.Please describe the appearance of the suture during the second procedure.:broken.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)?:yes were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue?:unknown.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation?:not reported.Please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).:unknown please provide the onset date/time of the reaction from the initial procedure.:unknown please describe any medical intervention required to treat the patient condition including medication name and results.:unknown.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.:unknown does the patient have a known allergic history to any medical devices, food and/or medication?:no.Was allergy testing performed? if so, please describe with results.:not reported.Are there any photos available?:no photo is available.Other relevant patient history/concomitant medications?:dr.Said the patient had no specific medical history.What is the physician¿s opinion as to the etiology of or contributing factors to this event?:since the symptoms improved after removal, there is a possibility that the product was the cause of this event.What is the patient's current status?:improved.Lot number?:unknown.If applicable, will product be returned? if so, please provide the return date and tracking information.:no device will be returned.

• Brand Name: SFX SYM PDS+ UNI 18IN 3-0 SA PS-2 PRM
• 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; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15734093
• MDR Text Key: 303075747
• Report Number: 2210968-2022-09122
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227743
• UDI-Public: 10705031227743
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 12/13/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A101
• Device Catalogue Number: SXPP1A101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/13/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 70 KG