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

Model Number	VCP753D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 was requested, and the following was obtained: "provide the specific number of patient events: one.Did the event occur during one or multiple patient procedures? during one procedure what is the total number of procedures? one.Have any of these events been previously reported to ethicon? no.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).This event occurred in one procedure.Lot number? no further information is available.No further information will be provided.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.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength -= 275 ¿g /m.Related to: 2210968-2022-07125.
Event or Problem Description
It was reported that a patient underwent a posterior lumbar interbody fusion on (b)(6) 2022 and suture was used.During the procedure, while the deep part of wound was closing with interrupted suturing, the suture broke continuously.It was unknown how many sutures were broken.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 1 S/A CT CR
• 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: 15325958
• Report Number: 2210968-2022-07124
• Device Sequence Number: 17763550
• Product Code: GAM
• UDI-Device Identifier: 10705031055339
• UDI-Public: 10705031055339
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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: VCP753D
• Device Catalogue Number: VCP753D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/31/2022
• 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