MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 3-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP713D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: what was being done when the needle detached from the suture (e.G.Removal from package, during passage through tissue, during tying, etc.)? no further information is available.Please provide lot number: no further information is available.Device return status/follow up? we regularly contact with sales rep about the device returning.No further information will be provided.Attempts have been 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.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the surgeon felt the needle was detached from the suture easier.It was a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/26/2021.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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: d9, h6.Additional h6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that an opened samples of product code vcp713 were received for evaluation.Visual inspection of the opened sample, the winding former have five needle/suture combination in slot 1 to 5 and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records couldn't be reviewed as the batch number is unknown.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as the device performed without any defect noted.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 472 g/m.

• Brand Name: VCL+ VIO 8X18IN 3-0 S/A RB-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11685946
• Report Number: 2210968-2021-03494
• Device Sequence Number: 11531388
• Product Code: GAM
• UDI-Device Identifier: 10705031054998
• UDI-Public: 10705031054998
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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 Model Number: VCP713D
• Device Catalogue Number: VCP713D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1