MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	YB257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample determined that it was received one opened sample that pertain to product code yb257.During visual inspection of the sample, the suture cannot be dispensed since have begun the degradation process caused by exposure to the environment.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that patient underwent an unknown procedure on an unknown date, and suture was used.During the surgery, when the product was taken out of the package, the suture broke.There were no adverse consequences to the patient.No further information was provided.

• Brand Name: MCRYL VIO 27IN 2-0 S/A CTB-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: 18784227
• Report Number: 2210968-2024-01829
• Device Sequence Number: 18230602
• Product Code: GAN
• UDI-Device Identifier: 10705031060029
• UDI-Public: 10705031060029
• 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

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: YB257
• Device Lot Number: SLMCQE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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