MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN(45CM) USP3-0(M2) S/A SH-1 CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDP777D

Device Problems Break (1069); Separation Failure (2547)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Additional information was requested, and the following was obtained: did the needle fall into the patient?=>no.Does a piece of the needle remain in the patient¿s tissue?=>no.The following information was requested, but unavailable: it was reported that the surgeon put the strong force enough to break the needle, could you please confirm it this is referring to a breakage needle? no further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-09611.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.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.

Event Description

It was reported that a patient underwent a total thyroidectomy procedure on (b)(6) 2022 and suture was used.The needle could not be detached from the suture during interrupted suturing on superficial fascia unless the surgeon put the strong force enough to break the needle.It was a control release needle.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/19/2022.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.H6 component code: g07002 no device problem found.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 one empty opened foil, one empty winding former, one needle-suture, and seven detached needles that pertain to product code pdp777d were returned for analysis the product is a control release, and each packet contains eight strands.In order to evaluate the conditions of the returned sample, the swage and attachment area was noted to be as expected and no damage, or breakage on the body, tip, or swage area was observed during the evaluation.No suture remnant could be observed into the barrel hole of the detached needles.The needle suture was examined along the strand to detect any issues related to no defects observed during the evaluation.A functional test was performed, to needle by resistance, pull force result meets the customer requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly 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.Related reports: 2210968-2022-09611 and 2210968-2022-09612.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.

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.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show devices with needle attached to suture segments.Please refer to the previously reported device analysis for full analysis details and conclusion.As part of the ethicon endo surgery quality process, all devices are manufactured, inspected, and released to approved specifications.Related events captured via 2210968-2022-09611.

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 was requested, and the following was obtained: product evaluations indicate that 2 actual samples have been returned.If the quantity involved should be 1, please provide further explanation.The quantity is (b)(4).Are the additional samples being returned unopened representative samples? yes two actual samples were returned for evaluation under this complaint.However, unopened samples will be returning additionally.Related reports: 2210968-2022-09611 and 2210968-2022-09612.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 5/18/2023.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: qty of product involved : (b)(4).Qty to be returned : (b)(4).The following additional information was requested: product evaluations indicate that 2 actual samples have been returned.If the quantity involved should be 1, please provide further explanation.Are the additional samples being returned unopened representative samples? related reports: 2210968-2022-09611.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 7/31/2023.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.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Overall inspection of the returned sample shows that it was received one detached needle in use condition, three needle-suture combinations that pertains to the product code pdp777d.The product code is control release and required eight strands per packet.Upon visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.In addition, the needle-suture combinations were visually inspected, and no anomalies or issues related to pull-off were observed during the evaluation.In addition, the needles were tested by resistance test to needle and met the requirements.The product code pdp777d contains an absorbable suture.As the sample was received open, the time of exposure to the environment could not be determined and the functional tests cannot be performed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the 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.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Ten unopened samples were returned that pertain to product code pdp777d.The product code is control release.In order to evaluate the condition of the returned samples, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no anomalies were observed during evaluation.The needles were tested by resistance test to needle and met the requirements.In addition, the functional test was performed, and the pull force result meet with the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of 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.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 6/28/2023.Additional information was requested, the following was obtained: how many additional unopened are going to be returned? 11 have those unopened representative samples been shipped? please provide any tracking information.The device has been received at sukagawa and will be shipped.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.

• Brand Name: PDS PLUS VIO 8X18IN(45CM) USP3-0(M2) S/A SH-1 CR
• 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: 15822839
• MDR Text Key: 307686978
• Report Number: 2210968-2022-09612
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PDP777D
• Device Lot Number: SGMMRU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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