MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date; and a suture was used.The suture was broken easily during use.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
(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: please clarify when the event occurred? during use.Please provide procedure name and date? unknown.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6 component code: g07002 device not returned.Related events captured via: 2210968-2024-02241, 2210968-2024-02242, 2210968-2024-02237, 2210968-2024-02236, 2210968-2024-02234, 2210968-2024-02233, 2210968-2024-02232, 2210968-2024-02231, 2210968-2024-02230.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/28/2024.Additional information was requested, the following was obtained: could you please confirm the quantity of broken sutures involved in this event?=>12.Did the event occur during one or multiple patient procedures?=>one.What is the total number of procedures?=>one.Have any of these events been previously reported to ethicon? =>no.If so, provide the respective reference number(s).- if this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).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: 2210968-2024-02241, 2210968-2024-02240, 2210968-2024-02242, 2210968-2024-02237, 2210968-2024-02236, 2210968-2024-02234, 2210968-2024-02233, 2210968-2024-02232, 2210968-2024-02231, 2210968-2024-02230, 2210968-2024-02758, 2210968-2024-02759.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/30/2024.H6 component code: g07002 no device problem found.H6 component code: c22 - photo analysis.H3 investigational summary: the product was returned to ethicon for evaluation.The returned sample determined that it was received seventeen unopened samples that pertains to product code y346h were returned.Upon initial inspection, of the samples, no external damages were observed on the packets.Additionally, a photo was provided, and with the same condition as the received sample.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.A functional test was performed using instron equipment and tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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.

• Brand Name: MCRYL VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18820688
• Report Number: 2210968-2024-02240
• Device Sequence Number: 4499797
• Product Code: GAN
• UDI-Device Identifier: 10705031058910
• UDI-Public: 10705031058910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Y346H
• Device Lot Number: SLMDUP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 04/30/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/28/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown