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

Model Number SXPP1A404

Device Problem Break (1069)

Patient Problem Wound Dehiscence (1154)

Event Date 09/01/2022

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 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.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? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.Surgeon¿s name?.

Event Description

It was reported that a patient underwent an unknown procedure in (b)(6) 2022 and barbed suture was used.Six months after surgery, it was found that the patella was dehiscent.Although it was unknown whether the suture breakage was the direct cause, x-ray showed obvious dehiscent.The patient will undergo re-operation.[progress] muscle suture separation.[treatment details] right knee 3r.The patient underwent surgery around the beginning of june, and visited the hospital for follow-up observation at 1 month (b)(6), 3 months (b)(6), and 6 months (b)(6) after the surgery, and underwent x-ray.Because the dehiscence of patella was found, re-operation is scheduled around the end of january.[product use details] the product was used for suturing on fascia.There were no supporting sutures.Epidermis was closed with a polysorb 3-0 suture.[surgeon¿s comment] this was the first such case in the hospital.It is unclear if the suture breakage is the direct cause of the event.Possibly, the layer of suturing by a surgeon who was a fellow was different.Although it is the first time in the hospital, surgeons who come for observing surgery have the opinion that there are not zero and there are several such cases.[other contributing factor] there may be differences in the layers and the suture methods with fellow surgeons.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/23/2023.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: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure, unknown.Date and name of index surgical procedure? total knee arthroplasty in (b)(6) 2022.The diagnosis and indication for the index surgical procedure? unknown.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? this procedure is total knee arthroplasty.On what tissue was the suture used? the product was used for suturing on fascia.What was the tissue condition (normal, thin, calcified, fragile, diseased)? tender was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? yes.Were two reverse stitches performed across the incision prior to closure? yes.What tissue dehisced? fascia.Is it known how the wound dehisced? ""completely dehisced"".Did the sutures barbs not engage in the tissue? doctors reported that the fellow doctor may not have sutured the proper layers.Did the suture pull out of the tissue? unknown.Did the suture break? if so, where was the break noted (termination, middle, end)? the surgeon said whether it was caused by suture breakage or not is unknown.In the reoperation, the suture was completely dissolved.Were there any precipitating stress factors that led to the suture breaking or pulling out of the tissue? the patient soft tissue was tender.Onset date/time of dehiscence? (# post op days) post op 3 months, a slight dehiscence was observed.Post op 6 months, a complete dehiscence was observed.How was the dehiscence managed? re-operation and sutured by non-absorbable thread.Please describe any surgical intervention required for the wound dehiscence including date and findings.Reoperation and re-suture was performed.In the reoperation, the suture used in index procedure was completely dissolved.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? not reported please describe the appearance of the suture during the second procedure.Completely dissolved.What symptoms did the patient experience following the index surgical procedure? onset date? unknown.Other relevant patient history/concomitant medications? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? it is unclear if the suture breakage is the direct cause of the event.Possibly, the layer of suturing by a surgeon who was a fellow was different.There may be differences in the layers and the suture methods with fellow surgeons.What is the patient's current status? unknown.Lot number? unknown.If applicable, will product be returned? if so, please provide the return date and tracking information.No sample will be retuned.Surgeon¿s name? unknown.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1
• 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: 16292985
• MDR Text Key: 308738100
• Report Number: 2210968-2023-00788
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227699
• UDI-Public: 10705031227699
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A404
• Device Catalogue Number: SXPP1A404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2023
• 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