MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP344H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).(b)(4).Device not returned.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please clarify: did the suture break before the procedure or during the procedure? procedure date? what tissue was being approximated or sutured when it broke? 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.
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on (b)(6) 2021 and suture was used.It was reported that when the package was opened and it was about to use the device to sew, the suture broke in the surgery.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/17/2022.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 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.H3 investigation summary: visual analysis of the returned product revealed that one opened sample product code vcp344 was received for evaluation.Upon to visual inspection of the returned sample, the swage and attachment area were noted to be as expected, the tip needle was observed with damaged, black and melted likely due to exposure to heat, the suture was received cutted at the end and body fluids at the surface.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.The product code vcp344 contains absorbable suture, as the sample was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information was requested and the following was obtained: it was reported that when the package was opened and it was about to use the device to sew, the suture broke in the surgery.Please clarify: did the suture break before the procedure or during the procedure?: according to the feedback of the sales, it happened during the procedure.Procedure date?: unk.What tissue was being approximated or sutured when it broke?: bladder peritoneum.Trade name - irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 g /m.

• Brand Name: VCL+ VIO 36IN 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.-SAN ANGELO; 3348 pulliam st; san angelo 76905 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13298918
• Report Number: 2210968-2022-00529
• Device Sequence Number: 5027751
• Product Code: GAM
• UDI-Device Identifier: 10705031052536
• UDI-Public: 10705031052536
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 07/31/2024
• Device Model Number: VCP344H
• Device Catalogue Number: VCP344H
• Device Lot Number: PJ4638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• 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