MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 12IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1A433

Device Problem Material Frayed (1262)

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

Event Date 01/01/2023

Event Type  malfunction  

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.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.In the provided photo it seems that suture began to fray, could you please clarify if the issue was pull off suture needle or fraying suture? please confirm.Is it possible to know if the patient suffered from any signs or consequences due to the issue? please provide more information.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.Component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.Related events captured via 2210968-2023-0069.

Event Description

It was reported that a patient underwent a ventral hernia repair procedure on an unknown date in 2023 and suture was used.When pulling the suture tight, the suture started to separate near the needle swage.The physician was still able to complete two back stitches.The procedure was completed successfully.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 2/14/2023.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.H6 component code: c22 - photo analysis.Additional information was requested, the following was obtained: fraying off the suture needle.The doctor was using cutting graspers on the robot.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that two small needle-suture pieces of product code sxpp1a433 were received for evaluation.During the visual assessment of the samples, that the swage and attachment area was as expected.Marks on the body needle that appears to be by a surgical instrument could be observed.The sutures were observed with body fluids and the suture extremes were noted to be broken.Damage and deformations were noticeable in the barbs.Crimping marks were observed on the suture surface that could be caused by a surgical instrument.The condition of the sample received indicates improper handling of the device.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed.The photo shows a needle with a small segment of damaged suture.A clear analysis could not be performed as the photo becomes distorted when magnified.Based on the photo review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: STFX SYM PDS+ UNI VIO 12IN 0 S/A CT-1
• 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: 16277500
• MDR Text Key: 308976931
• Report Number: 2210968-2023-00698
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031245143
• UDI-Public: 10705031245143
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: SXPP1A433
• Device Catalogue Number: SXPP1A433
• Device Lot Number: RMMMSS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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