MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A X-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP460H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot number qamehm /vcp460w, and no non-conformances related to the reported complaint condition were identified.Attempts are being 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.Additional information was requested and the following was obtained: procedure name: an arrhythmia surgery.Trade name - irgacare® active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 ug/m.Note: events reported via mw# 2210968-2021-01322.
Event or Problem Description
It was reported that the patient underwent an arrhythmia surgery on (b)(6) 2021 and suture was used.When tying the suture during continuous suturing, the weaving of the suture was torn except for center suture.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/23/2021.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.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code vcp460h was received for evaluation, the swage and attachment area was noted to be as expected, the suture piece was observed with marks on the surface and was cut appears to be by use of the surgical instrument.The product code vcp460 contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The condition of the sample received indicates improper handling of the device.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• Brand Name: VCL+ VIO 27IN 3-0 S/A X-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11314693
• Report Number: 2210968-2021-01321
• Device Sequence Number: 13632055
• Product Code: GAM
• UDI-Device Identifier: 10705031053410
• UDI-Public: 10705031053410
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 12/31/2024
• Device Model Number: VCP460H
• Device Catalogue Number: VCP460H
• Device Lot Number: QAMEHM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1