MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP423H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.H3 device analysis: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample determined that one opened folder with one detached needle and one suture piece along with an empty labeled winding former that pertains to product code vcp423h were received for evaluation.In order to evaluate the conditions of the returned sample, the hole of the needle was noted with marks that appear to be by surgical instrument and was observed with suture remnant.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.In addition, the suture end was cut possibly caused by a surgical instrument.A functional test was not performed, due to the needle was received detached from the suture.The condition of the sample received indicates improper handling of the device.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was received via: yes, needle was retrieved successfully no adverse events.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2023 and suture was used.During the procedure, the dr was attempting to close a port site with vicryl suture vcp423, and had taken one bite through the tissue, when the needle broke off the suture.The needle had to be retrieved, and the suture was removed and set aside.This is the first time the surgeon has experienced this.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17646646
• Report Number: 2210968-2023-06299
• Device Sequence Number: 7979159
• Product Code: GAM
• UDI-Device Identifier: 10705031053113
• UDI-Public: 10705031053113
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K032420
• 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): 08/29/2023

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: VCP423H
• Device Lot Number: SL2BPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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