MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 3-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J772D
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
Product complaint #(b)(4).If further details are received at a later date a supplemental medwatch will be sent.H3 evaluation: the product was returned to ethicon for evaluation.One open sample was returned for analysis.Product code which is a control release and requires eight strands per packet.During the visual inspection of the returned sample, the sutures could not be dispensed since has begun with the process of degradation this caused the sutures to be broken.Per the sample condition, the functional test cannot be performed.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed.The reported event is confirmed.The condition of the package is indicative of handling and storage issues that occurred outside of ethicon control.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
Event or Problem Description
It was reported a patient underwent an unknown surgery on an unknown date and suture was used.It was found that the suture had already worn when the package was opened.It was a control release needle.Further details are not provided.There were no adverse consequences to the patient.Upon receipt and analysis of product sample the package was damaged and it has begun with the process of degradation.

• Brand Name: VCL CT BRD VIO 8X18IN 3-0 S/A SH-1 CR
• 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: 21230614
• Report Number: 2210968-2025-00920
• Device Sequence Number: 15338897
• Product Code: GAM
• UDI-Device Identifier: 10705031042872
• UDI-Public: (01)10705031042872(17)260131(10)RBMCZM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: J772D
• Device Lot Number: RBMCZM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2021
• 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