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

Model Number	Y399H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: g07002.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: what is the lot number? unk.Device return follow-up.The device has been received at sukagawa and will be shipped.Please check rmao.The following additional information was received: product code: y339h => y399h.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.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn surgery on (b)(6) 2023 and suture was used.During the procedure, the suture had been detached from the needle.It was not a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/27/2023.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received one open sample that pertain to product code y399h.During the visual inspection of the sample, the swage and attachment area was noted to be as expected.The barrel hole was examined under 10x magnification for suture remnant, and none was observed.The suture end was examined and there isn¿t sufficient impression at the swage end, resulting in a light swage.Based on the information currently available, light swage issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the quality system.Additional complaint information monitoring for potential safety signals will be 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 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16413670
• Report Number: 2210968-2023-01291
• Device Sequence Number: 16985379
• Product Code: GAN
• UDI-Device Identifier: 10705031059108
• UDI-Public: 10705031059108
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Model Number: Y399H
• Device Catalogue Number: Y399H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown