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

Model Number	VCP352H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.During the procedure, the incident happened during the closing of second layer of uterus.The scrub nurse noticed the needle is incomplete (no tip).Surgeon was informed directly.They looked for the tip in the patient abdomen cavity or table and floor, where to be found, and no needle found.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).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.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.Additional information was requested, and the following was obtained via: were x-rays taken to locate the needle piece(s)? yes.Was there any additional tissue damage as a result of searching for the needle piece? no.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.Events reported via: 2210968-2022-05342.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/23/2022.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.H6 component code: c22 - photo analysis.H3 investigational summary ¿ photo analysis: this is an analysis of three photos submitted to ethicon for evaluation.During visual analysis the following was observed: the photo shows two pins of product code vcp352h.The needles were observed with use, bodily fluids, marks, distorted in the original curvature and broken at the tip of one of the needles.Based on the pi-16553257013726875 review, the event described breakage needle confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.As part of the ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/8/2022.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The second needle was bent, but not fractured, therefor no additional analysis was performed.The fracture surfaces were examined in multiple locations to determine the fracture mode.The fracture surface contained microvoid coalescence, evidence of a ductile fracture mode.Mechanical damage in the form of indents and scratches were observed coincidental to the fracture.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.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this batch.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 0 S/A CT
• 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 ; 9083863534
• MDR Report Key: 14983412
• Report Number: 2210968-2022-05341
• Device Sequence Number: 5022236
• Product Code: GAM
• UDI-Device Identifier: 10705031052635
• UDI-Public: 10705031052635
• Combination Product (Y/N): Y
• Initial Reporter Country: SA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2022

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: VCP352H
• Device Catalogue Number: VCP352H
• Device Lot Number: RBBCKKW0
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 07/22/2022; 08/10/2022; 09/28/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/08/2022; 08/23/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown