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

Model Number	VCP338H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a vascular procedure on 4/22/2022 and suture was used.During use on the patient the needle broke when the surgeon was closing the subcutis.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Photo analysis: visual analysis of the images submitted for evaluation determined that a needle with a section of suture attached could be observed inside a plastic container.Image is not clear to determine failure mode or reported condition.As part of our quality process, manufacturing records were reviewed for this lot's serial number and manufacturing standards were met prior to the release of this lot.No conclusion could be reached as to the cause of the reported complaint, as the sample was not returned for analysis.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.Additional information about complaints is tracked for potential safety signals through complaint trends as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: what was the size of the needle used? ct-1.Was more than half the needle retained in the patient? no needle in the patient.Was the procedure completed successfully? yes.Was there any adverse patient outcome? no.Was the needle fully retrieved? yes.X-rays taken? results? no.Any additional tissue dissection damage due to searching for needle? no lot number?: rbbcgjc0.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 ¿ = 2360 g/m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/6/2022.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.Additional information: d9, h3, h6.H3 investigational summary: a failed suture needle was submitted fractographic evaluation.The component was identified as product code vcp338h.It was requested that assess the fracture mode of the failure.A fracture was observed near the tip of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength -= 275 g /m.

• Brand Name: VCL+ VIO 27IN 3-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert- koch strass1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14545289
• Report Number: 2210968-2022-04127
• Device Sequence Number: 6774617
• Product Code: GAM
• UDI-Device Identifier: 10705031052451
• UDI-Public: 10705031052451
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• PMA/510(K) Number: K132580
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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 Expiration Date: 01/31/2024
• Device Model Number: VCP338H
• Device Catalogue Number: VCP338H
• Device Lot Number: RBBCGJC0
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown