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 Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an abdominoplasty procedure on (b)(6) 2023 and barbed suture was used.During the procedure, surgeons found a box of frayed stratafix threads right after the needle.When they changed the box with a different lot, the problem was no longer encountered.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: could you please clarify when did the issue occurred (during removal from package /during passage through tissue/ during tying / post-op)? please confirm * what do you mean by "frayed stratafix threads right after the needle"? * what is the total number that were defect (frayed suture)? answer: the problem was found on 6 out of 12 threads in the package during an abdominoplasty.After the first passage, the surgeon noticed that the thread was fraying near the needle and the beginning of the anchors.The "defective" threads were thrown away because they were used in the operating field.The sales rep will ship the box with the remaining 6 products.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.Events reported via: 2210968-2023-00411, 2210968-2023-00412, 2210968-2023-00413, 2210968-2023-00414, 2210968-2023-00416.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: the sales rep reported that the product is in shipment.We are waiting for receipt of the product.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/5/2023.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.The following additional information was received: customer account: (b)(6).Related reports: 2210968-2023-00411, 2210968-2023-00412, 2210968-2023-00413, 2210968-2023-00414, 2210968-2023-00415, 2210968-2023-00416.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/30/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and was conducted on the returned devices.The returned samples determined that it was received six unopened samples that pertain to the product code sxpp1a444.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to fraying suture or anomalies were observed during the evaluation.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Related reports: 2210968-2023-00411, 2210968-2023-00412, 2210968-2023-00413, 2210968-2023-00414, 2210968-2023-00415, 2210968-2023-00416.

• 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16214451
• MDR Text Key: 308837254
• Report Number: 2210968-2023-00415
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031245235
• UDI-Public: 10705031245235
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K141776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A444
• Device Catalogue Number: SXPP1A444
• Device Lot Number: SEMCXH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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