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

Model Number	Y359H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: ¿ when was the suture torn (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify ans : during handling prior to use on patient.¿ could you please confirm the quantity of sutures torn? ans : 4pc.¿ did the event occur during one or multiple patient procedures? ans : one.¿ what is the total number of procedures? information not available.¿ have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Information not available.¿ if this event occurred in multiple procedures, please provide information requested above for each patient event.Investigational summary: one opened box with twenty-seven packets of product code y359h were returned to ethicon for evaluation.Visual and functional test were performed on the retuned device.As per the sampling plan, a visual inspection was performed on thirteen samples, no defects were found on the packages.The packets were opened, 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 issue related to breakage suture or anomalies were observed during evaluation.Also, the functional test was performed using a instron and the tensile force were above the minimum 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.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, the suture became torn during operation.There were no patient consequences reported.Additional information was requested.

• Brand Name: MCRYL VIO 36IN 1 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 15284814
• Report Number: 2210968-2022-06888
• Device Sequence Number: 2291892
• Product Code: GAN
• UDI-Device Identifier: 10705031059047
• UDI-Public: 10705031059047
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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 Expiration Date: 08/31/2025
• Device Model Number: Y359H
• Device Catalogue Number: Y359H
• Device Lot Number: QKMERX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/24/2022
• Date Device Manufactured: 09/16/2020
• 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