MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A RB-1 MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y305H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One open sample was received for analysis.Product code: y305h.During visual inspection of the detached needle, the swage and attachment area was noted to be as expected.The barrel hole was examined, and remnant of suture was observed.The suture cannot be dispensed since have begun the degradation process this condition probably caused the detached needle.The time of exposure of the suture to the environment could not be determined.Per the sample condition, the functional test cannot be performed.The foil was visually inspected, and no anomalies were observed during the evaluation.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional information was requested, and the following was obtained via: if possible, please confirm if the suture was found broken in separate pieces or if the entire suture was detached from the needle.Detached from the needle please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.Tracking number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an urology da vinci procedure on an unknown date and suture was used.Before use on the patient, it was reported by a sales rep that, when one package was opened, the suture and needle were cut off like a control release needle.It was noticed before use, so another product was used as a replacement.It was not a control release needle.During visual inspection of the detached needle, the swage and attachment area was noted to be as expected.The barrel hole was examined, and remnant of suture was observed.The suture cannot be dispensed since have begun the degradation process this condition probably caused the detached needle.The time of exposure of the suture to the environment could not be determined.Per the sample condition, the functional test cannot be performed.The foil was visually inspected, and no anomalies were observed during the evaluation.Further details are not provided from the hp.There were no adverse consequences reported.Additional information was requested.

• Brand Name: MCRYL VIO 27IN 3-0 S/A RB-1 MP
• 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: 21689919
• Report Number: 2210968-2025-03135
• Device Sequence Number: 21159205
• Product Code: GAN
• UDI-Device Identifier: 10705031058712
• UDI-Public: (01)10705031058712(17)47118(10)UAMHPT
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: Y305H
• Device Lot Number: UAMHPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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