MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 2-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP775D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Additional information was requested and the following was obtained: did the needle fall into the patient? it is not certain, but there was a possibility that the needle fell into the patient.If yes, was the needle piece removed from the patient during the same procedure? were x-rays taken to locate the needle? when x-ray was taken, it was confirmed that there was a shadow like a needle tip.Was any other tissue damaged as a result of searching the needle? they did not search the needle.What is the lot number? sg2abc.Attempts are being 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.(b)(4).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 an orthopedic ankle procedure on an unknown date on (b)(6) 2022 and suture was used.There was a possibility that the needle was broken when the subcutaneous was sutured.At that time, the surgeon did not realize it and after the surgery when an x-ray was taken it was confirmed that there was a shadow like a needle-tip.The needle which was used in the surgery was discarded.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 2/2/2023.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: - can you please clarify the issue experienced with the additional reported product (vcp790d).=>impacted product is only one, but which needle(vcp775d or vcp790d)contribute was unknown.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned devices.Visual analysis of the returned sample revealed that six packets and one opened sample that pertain to product code vcp775d were returned for analysis.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be as expected.The needles were intact and no damage, or breakage on the body, tip, or swage area was observed during the evaluation.A functional test was performed, to needle by resistance and met the requirements.The event described could not be confirmed as the device performed without any defect noted.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: VCL+ VIO 8X18IN 2-0 S/A SH CR
• 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 TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16077495
• Report Number: 2210968-2022-10791
• Device Sequence Number: 14975501
• Product Code: GAM
• UDI-Device Identifier: 10705031055537
• UDI-Public: 10705031055537
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: VCP775D
• Device Catalogue Number: VCP775D
• Device Lot Number: SG2ABC
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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