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

Model Number SXPP1A301

Device Problems Material Frayed (1262); Material Separation (1562)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint(b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Please clarify when the event occurred? 2.How the procedure was completed.3.Was there any adverse consequence associated with the patient? 4.Name of the procedure? 5.Please provide procedure date.6.Status of product return.The event displays lot: shmhla but the ip displays lot: shmbpb.Please advise which is the correct lot? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.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 a patient underwent a discectomy on (b)(6) 2023 and barbed suture was used.While closing the wound and the needle snapped from the suture.No adverse consequences were reported.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/20/2023.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.Additional information was requested, the following was obtained: it did not break but started getting thinner and thinner, making surgeon afraid to use it.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer? additional information was requested, and the following was obtained: 1.Please clarify when the event occurred? (b)(6) 2023.2.Please provide procedure date? (b)(6) 2023.The following information was requested, but unavailable: 1.How the procedure was completed 2.Was there any adverse consequence associated with the patient? 3.Name of the procedure? 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.Based on the previous response the correct lot for this event is from the event description, shmhla.However, samples from lot shmbpb were returned for evaluation.Please clarify if there was any quality issue with the sutures returned from lot shmbpb.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that seven unopened samples that pertain to the product code sxpp1a301 were received.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Corrected information: d 4.Lot, d 4.Expiration date, d 9.Device available for evaluation?, h3.Device evaluated by manufacturer?, h4.Device manufacture date, h6.Medical device problem code, h6.Component code, h6.Type of investigation, h6.Investigation findings, h6.Investigation conclusions.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-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: 17374925
• MDR Text Key: 320076239
• Report Number: 2210968-2023-05302
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227712
• UDI-Public: 10705031227712
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K113004
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A301
• Device Catalogue Number: SXPP1A301
• Device Lot Number: SHMBPB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• 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