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

Catalog Number	VCP334H
Medical Device Problem Code	Break (1069)
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
(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.H6 component code: g07002 device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you identify the lot number of the product that was used? what was done to retrieve the broken piece? for example, another incision, second surgery? was there any additional tissue damage as a result of searching for the needle piece? was additional dissection required in other organs/tissues other than the target tissue? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).
Event or Problem Description
It was reported that a patient underwent a lap appendectomy on an unknown date and suture was used.During the procedure, the tip of the suture broke off in the skin when the surgeon was suturing closed.The surgeon removed the piece of the broken suture from the patient.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/6/2024.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.Additional information was requested, the following was obtained: can you identify the lot number of the product that was used? unknown.What was done to retrieve the broken piece? for example, another incision, second surgery? broken piece was removed during the surgery.Was there any additional tissue damage as a result of searching for the needle piece? was additional dissection required in other organs/tissues other than the target tissue? no.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) or nurse.

• Brand Name: VCL+ VIO 27IN 0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18656057
• Report Number: 2210968-2024-01026
• Device Sequence Number: 7129006
• Product Code: GAM
• UDI-Device Identifier: 10705031052413
• UDI-Public: 10705031052413
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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: VCP334H
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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