MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP486H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2022 and the suture was used.During surgery, the tip of the needle breaks, this occurred after changing from one suture to another.There were no adverse patient consequences reported.Additional information has been requested.
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.When was the needle broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify did the needle fall into the patient? if yes, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? does a piece of the needle remain in the patient¿s tissue? if yes, are any plans in place to remove the needle piece in future? what tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? please provide the lot number: device return status: did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.Events reported via 2210968-2022-07874, 2210968-2022-07875, 2210968-2022-07876, 2210968-2022-07877, 2210968-2022-07878, 2210968-2022-07879, 2210968-2022-07880, 2210968-2022-07881, 2210968-2022-07882, and 2210968-2022-07883.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/12/2022.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.H6 component code: g07002 no device returned.Additional information was requested, the following was obtained: was surgery delayed due to the reported event? no (another suture was opened).Was procedure successfully completed? yes.Were fragments generated? no.Patient status/ outcome / consequences none was other medical intervention? no.Related reports: 2210968-2022-07874, 2210968-2022-07875, 2210968-2022-07876, 2210968-2022-07877, 2210968-2022-07878, 2210968-2022-07879, 2210968-2022-07880, 2210968-2022-07881, and 2210968-2022-07883.

• Brand Name: VCL+ VIO 36IN 1 S/A CP
• 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: 15485570
• Report Number: 2210968-2022-07882
• Device Sequence Number: 15487088
• Product Code: GAM
• UDI-Device Identifier: 10705031053618
• UDI-Public: 10705031053618
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 12/12/2022

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: VCP486H
• Device Catalogue Number: VCP486H
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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