MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y605H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
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-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One winding former with a needle and suture outside its packaging was received for analysis.Product code y605h.Upon visual assessment of the returned sample, the swage and attachment area were noted as expected; the barrel hole of the needle was examined under magnification and remnant suture was observed.To the environment could not be determined.In addition, the foil was not returned for evaluation.The suture could not be dispensed since it has begun with the process of degradation and the time of exposure of the suture to the environment could not be determined.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.Per the sample condition, the functional test cannot be performed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2024 and suture was used.During the procedure, it was reported that the problem of pulling off suture needle had happened before using on patient during surgery.Changed another one to complete the surgery.No additional information could be provided.There were no adverse consequences reported.Additional information was requested.

• Brand Name: MCRYL VIO 27IN 2-0 S/A UR-6
• 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: 20450255
• Report Number: 2210968-2024-10752
• Device Sequence Number: 21140219
• Product Code: GAN
• UDI-Device Identifier: 10705031059481
• UDI-Public: (01)10705031059481(11)220210(17)270131(10)SBMDQJ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/15/2024

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: Y605H
• Device Lot Number: SBMDQJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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