MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 2-0 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP472H
Medical Device Problem Code	Material Separation (1562)
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 a patient underwent an unknown procedure on an unknown date in 2022 and suture was used.During tying, the needle came loose from the suture.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 product not returned.Additional information provided: was surgery delayed due to the reported event? unknown; was procedure successfully completed? unknown; were fragments generated? unknown; if yes, were they removed easily without additional intervention? unknown; patient status/ outcome / consequences; was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown; is the patient part of a clinical study unknown; (b)(4).Device property of none; device in possession of none; (b)(4) ; device property of none; device in possession of none.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Could you please provide the lot number? please perform and document the follow up attempt for product return.Note: events reported on: 2210968-2023-00276.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 275 g/m vicryl ce.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/31/2023.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.Investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Upon visual analysis of the product, it was observed one paper lid, one empty winding former and one detached needle that pertain to product code vcp472h.The suture was not returned for analysis.The needle hole and swage area were noted with marks that appear to be caused by a surgical instrument.The barrel hole was examined under 20x magnification, and no suture remnant could be observed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No further investigation will be conducted on this complaint due to external cause.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL+ VIO 36IN 2-0 S/A CP-1
• 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: 16139077
• Report Number: 2210968-2023-00277
• Device Sequence Number: 20462235
• Product Code: GAM
• UDI-Device Identifier: 10705031053533
• UDI-Public: 10705031053533
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: VCP472H
• Device Catalogue Number: VCP472H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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