MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A TF; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J434H
Medical Device Problem Code	Material Frayed (1262)
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-conformances were identified.Additional information was requested, and the following was obtained via: are there photos available of the "fluffed up" sutures? =yes was fraying observed on the affected sutures? =yes what is the procedure name and date? =unk 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).H3 investigation summary: the product was returned to ethicon for evaluation.One needle suture combination was received for analysis.The product code is j434h.During the visual inspection of the returned sample.The swage and attachment were noted areas as expected.The suture was examined along the strand and fraying suture could be observed.The product code j434h contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.In addition, six photos were provided showing frayed suture along of strand and one empty foil packet that belongs to product code j434h.Based on the information currently available, damaged suture was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.
Event or Problem Description
It was reported that an animal underwent an unknown veterinary surgery on an unknown date and suture was used.During the procedure, it was reported by a sales rep that, the five sutures could not be used because they become fluffed up during use.It was not a control release needle.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A TF
• 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: 21414999
• Report Number: 2210968-2025-01803
• Device Sequence Number: 18086504
• Product Code: GAM
• UDI-Device Identifier: 10705031039841
• UDI-Public: (01)10705031039841(17)281031(10)TMMHXR
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 02/19/2025

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: J434H
• Device Lot Number: TMMHXR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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