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

Model Number	VCP334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unspecified orthopedic procedure on (b)(6) 2023 and suture was used.The needle tip snapped off into a patient.Further imaging and investigation is needed to find the tip.There is no reported harm to the patient, however, the needle tip does remain in-situ inside patient.Additional information has been requested.
Additional Manufacturer Narrative
(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.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.Were x-rays taken to locate the needle? was there any patient consequence or injury? what is the patient¿s current health status and condition? was any other tissue damaged as a result of searching the needle? could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more information.What is the lot number? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/22/2023.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

• 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: 16763821
• Report Number: 2210968-2023-02783
• Device Sequence Number: 17668619
• Product Code: GAM
• UDI-Device Identifier: 10705031052413
• UDI-Public: 10705031052413
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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 Model Number: VCP334H
• Device Catalogue Number: VCP334H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/22/2023
• 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