MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 12IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A435
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional 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 - (b)(6).¿ strength ¿ = 2360 g/m component code: (b)(4) device not returned.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? was the index hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? 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? was there any triggering event prior to present recurrence? (e.G.Sneezing, coughing, strenuous activity)? what symptoms did the patient experience following the index surgical procedure? onset date? how was the recurrence diagnosed? please describe any medical/surgical intervention required for this suture event including dates and results.Did the patient require re-operation for the recurrent hernia? if the patient did undergo re-operation, can you describe the appearance of the stratafix suture during second procedure? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? did the suture pull away from the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient underwent ventral hernia repair procedure on an unknown date and a barbed suture was used for the defect.The procedure was done using the robot.Post-op, the patient experienced a recurrent ventral hernia.The mesh was intact but defect was open.Additional information was requested.
Additional 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.Additional information: e1, e3 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? date unknown, but surgeon said a ventral hernia repair was the index hernia repair associated with this event performed on primary or recurrent hernia? unknown what was the defect size/type/location of the hernia associated with this event? unknown on what tissue was the suture used? fascia what was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? unknown were two reverse stitches performed across the incision prior to closure? unknown but surgeon is aware of this termination technique.Was there any triggering event prior to present recurrence? (e.G.Sneezing, coughing, strenuous activity)? unknown what symptoms did the patient experience following the index surgical procedure? onset date? unknown how was the recurrence diagnosed? surgeon said it was diagnosed as recurrent please describe any medical/surgical intervention required for this suture event including dates and results.Unknown did the patient require re-operation for the recurrent hernia? unknown if the patient did undergo re-operation, can you describe the appearance of the stratafix suture during second procedure? unknown did the stratafix suture break? if so, where was the break noted (termination, middle, end)? unknown did the suture pull away from the tissue? unknown did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? unknown what is the patient's current status? unknown lot number? unknown surgeon¿s name? dr.Farid zehtab if applicable, will product be returned? if so, please provide the return date and tracking information.Not available for return.

• Brand Name: STFX SYM PDS+ UNI VIO 12IN 1 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18610475
• Report Number: 2210968-2024-00793
• Device Sequence Number: 2406545
• Product Code: NEW
• UDI-Device Identifier: 10705031245211
• UDI-Public: 10705031245211
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1A435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown