MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 0 S/A FSL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J587H
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown surgery on an unknown date and suture was used.During the procedure, when the veterinarian tightened the knots for vascular ligations the thread broke without exerting excessive tension, sometimes on the side of the small head sometimes on the side of the big head.In addition, the thread held in the pliers was crumbling.The surgeries could be carried out using other threads from another reference without impact on the animals to date.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/19/2024 h6 component code: g07002 - device not returned 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.The single complaint was reported with multiple events.Additional information was requested, the following was obtained: - please confirm how many procedures were affected by the reported issue (the wire broke during surgery).Vet use - 4 surgery impacted : vet use 4 surgery impacted : 3 dog castrations and 1 female dog ovariectomy date: (b)(6) 2023 when the veterinarian tightened the knots for vascular ligations the thread broke without exerting excessive tension, sometimes on the side of the small head sometimes on the side of the big head.In addition, the thread held in the pliers was crumbling.The surgeries could be carried out using other threads from another reference without impact on the animals to date.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: VCL CT BRD VIO 27IN 0 S/A FSL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18546179
• Report Number: 2210968-2024-00539
• Device Sequence Number: 9081087
• Product Code: GAM
• UDI-Device Identifier: 10705031041486
• UDI-Public: 10705031041486
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2024

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: J587H
• Device Lot Number: TGBBPXT0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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