MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A401

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a scoliosis repair procedure on an unknown date and barbed suture was used to close the fascia.The patient came for their post-op visit on (b)(6) 2022 and was having drainage from the wound.The surgeon took the patient back to the operating room and found that the fascia had completely dehisced.The stratafix had broken down.The patient has an infection.The surgeon cleaned it out and placed a wound vac.Unknown the current condition of patient.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 ¿g/m (b)(4).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 lot number reported in this event? are there sterile samples from the reported finished goods lot available for testing? is the type of the infection known or cultures performed? if so what were the culture results? did the patient have any pre-existing health issues that could contribute to healing issues which could have contributed to the event? for example, medications, past reactions or allergies, weight, age, diabetes, obesity, etc? did the patient fall or injury themselves in a way that may have affected the surgical area? was the patient compliant with post-op instructions? what is the patient¿s current health status and condition? were antibiotics prescribed? also the doctor¿s experience, product placement, technique, type of material, type of procedure? were any of the instruments in the o.R.Tested? if so, what were the results? how long post-op did the patient present with symptoms? is another surgery planned for the removal of the device? which suture was used on the fascia? what tissue layer was sxpd2b405 stratafix spiral pdo used on? what tissue layer was sxpp1a401 stratafix symmetric pds+ used on? did both layers have suture break down? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date of index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? 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? please describe any surgical intervention required for this suture event including dates and results.Please describe any medical intervention performed including medication name and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix suture during second procedure, if applicable? what is the physician¿s opinion as to the etiology of or contributing factors to this event? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? how much and what type of drainage is present in this wound? were any pre-op cleansing procedures changed recently? if yes, please describe.

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: a3, b7, h6.Additional information was requested, and the following was obtained: ¿ please provide the lot number reported in this event? unknown ¿ are there sterile samples from the reported finished goods lot available for testing? unknown.¿ is the type of the infection known or cultures performed? if so what were the culture results? unknown.¿ did the patient have any pre-existing health issues that could contribute to healing issues which could have contributed to the event? for example, medications, past reactions or allergies, weight, age, diabetes, obesity, etc? obesity ¿ did the patient fall or injury themselves in a way that may have affected the surgical area? unknown.¿ was the patient compliant with post-op instructions? unknown.¿ what is the patient¿s current health status and condition? stable.At home with a picc line and on iv antibiotics ¿ were antibiotics prescribed? yes ¿ also the doctor¿s experience, product placement, technique, type of material, type of procedure? not sure what is being asked here.¿ were any of the instruments in the o.R.Tested? if so, what were the results? no ¿ how long post-op did the patient present with symptoms? still having symptoms more than a month post-op.¿ is another surgery planned for the removal of the device? surgery was already performed to remove the suture.Which suture was used on the fascia? sxpp1a401 what tissue layer was sxpd2b405 stratafix spiral pdo used on? subcuticular what tissue layer was sxpp1a401 stratafix symmetric pds+ used on? fascia did both layers have suture break down? yes please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure-teenage male, bmi is unknown date of index surgical procedure? november 2 what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open 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? yes were two reverse stitches performed across the incision prior to closure? yes please describe any surgical intervention required for this suture event including dates and results.Suture was surgically removed the end of november.Patient had a wound vac placed for a while.Patient was sent home with a picc line and iv antibiotics.Please describe any medical intervention performed including medication name and results.Unknown did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no did the stratafix suture break? if so, where was the break noted (termination, middle, end)? unknown.Surgeon said the wound dehisced but did not comment on the suture.Can you describe the appearance of the stratafix suture during second procedure, if applicable? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? patients obesity, inability to keep wound dry were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? yes how much and what type of drainage is present in this wound? unknown.Were any pre-op cleansing procedures changed recently? if yes, please describe.No.Corrected information: b3 - exact date of event is unknown.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 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: 15915731
• MDR Text Key: 304805743
• Report Number: 2210968-2022-09965
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219342
• UDI-Public: 10705031219342
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113004
• 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
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A401
• Device Catalogue Number: SXPP1A401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• 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 Sex: Male