MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 1 S/A CT; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1A444

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Seroma (2069)

Event Date 01/01/2022

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).Attempts are being 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 first 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? did the patient have a wound dehiscence? what tissue dehisced? onset date/time of dehiscence (# of days post-op)? how was the dehiscence managed? please describe any medical/surgical intervention required for this suture event including dates and results.What was the date of the re-operation (the second procedure)? what was the reason the patient underwent re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? it was stated that during the second procedure, the doctor found the fascial closure to be disrupted, and the suture was noted to be "delaminated".Please provide further details on what is meant by delaminated.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix during the second procedure? were there any precipitating stress factors for the suture breakage or pulling out of the tissue? did the patient have a seroma? if yes, please describe any treatment required for the seroma.Was the pds suture for the fascial defect used during the initial procedure or during the re-operation? was there any deficiency or issue related to the pds suture? if yes, please describe 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.Note: related events reported via 2210968-2023-00084.

Event Description

It was reported that a patient underwent an unknown posterior spinal procedure on an unknown date and a barbed suture was used.Four weeks post-op, the patient underwent re-operation for a wound washout and closure.During this second procedure, the doctor found the fascial closure to be disrupted, and the suture was noted to be "delaminated".It was reported that the patient had a possible seroma, upon further questioning, it was determined that the surgeon's closure technique for this wound was to start on either end with a single strand, sewing to the middle and overlapping each.The surgeon did not back-stitch either strand.The fascial defect was closed with a traditional suture.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/19/2023.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/10/2023.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.Date and name of index surgical procedure (the first procedure)? posterior spinal fusion.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? fascia.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? his closure technique for this wound was to start on either end with a single strand, sewing to the middle and overlapping each.He did not back-stitch either strand.Did the patient have a wound dehiscence? yes.What tissue dehisced? fascia.Onset date/time of dehiscence (# of days post-op)? 4 weeks post op.How was the dehiscence managed? reoperation.Please describe any medical/surgical intervention required for this suture event including dates and results.Reoperation.During the reoperation, it was noted that the barbed suture was delaminated.Split down the center so there were barbs on the right and barbs on the left.What was the date of the re-operation (the second procedure)? what was the reason the patient underwent re-operation? fascial suture broke.Collection of fluid sub q what symptoms did the patient experience following the index surgical procedure? onset date? 4 weeks post op collection of fluid sub q.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? suture delaminated noted during reoperation.It was stated that during the second procedure, the doctor found the fascial closure to be disrupted, and the suture was noted to be "delaminated".Please provide further details on what is meant by delaminated.Split down the center so there were barbs on the right and barbs on the left.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? yes.Can you describe the appearance of the stratafix during the second procedure? during the reoperation, it was noted that the barbed suture was delaminated.Split down the center so there were barbs on the right and barbs on the left.Were there any precipitating stress factors for the suture breakage or pulling out of the tissue? did the patient have a seroma? if yes, please describe any treatment required for the seroma.Collection of fluid sub q.Reoperation.Was the pds suture for the fascial defect used during the initial procedure or during the re-operation? used during reoperation.Was there any deficiency or issue related to the pds suture? if yes, please describe - no 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? doing well now.Lot number? surgeon¿s name? dr.(b)(6).If applicable, will product be returned? if so, please provide the return date and tracking information.Will be shipped fed ex.Additional information was requested, and the following was obtained: sales rep stated that it is possible that there could be other contributing factors that led to these events.Pds suture that was mentioned in the event description was only used during the reoperation in this patient and there is no reported complaint for the pds suture.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 1 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 16108863
• MDR Text Key: 306779201
• Report Number: 2210968-2023-00085
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031245235
• UDI-Public: 10705031245235
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K141776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A444
• Device Catalogue Number: SXPP1A444
• Device Lot Number: SEMJAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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