MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 18IN 5-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP391H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an apical procedure on (b)(6) 2024 and suture was used.During the procedure, what has happened/could have happened? during apical surgery, 3 packages of sutures were taken out, of which two detached the needle from the thread.In one case, it happened on the first use in the gingiva and the other after some sutures were set.The sutures in question are vicryl plus 5-0.What injury/discomfort has/could have been (reporter's comment)? no harm occurred as another suture was used and new sutures could be put.Probable cause (from the reporter) does not know.Manufacturing errors? urgent action taken (rapporteur's comment)? in the moment, new sutures were brought out.And then a deviation report is filed.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 component code: g07002 - device not returned.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.Attempts have been made to retrieve the device.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.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: were there any patient consequences? no can you identify the lot number of the product that was used? lot nr tcbdccwo 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).Tel: (b)(6).
Additional Manufacturer Narrative
(b)(4).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.

• Brand Name: VCL+ VIO 18IN 5-0 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.-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: 20078595
• Report Number: 2210968-2024-09007
• Device Sequence Number: 7847512
• Product Code: GAM
• UDI-Device Identifier: 10705031052918
• UDI-Public: (01)10705031052918(17)260228(10)TCBDCCW0
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• PMA/510(K) Number: K132580
• 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,Followup
• Report Date (Section B): 10/17/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: VCP391H
• Device Lot Number: TCBDCCW0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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