MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 4-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP441H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a breast mass excision procedure on an unknown date and suture was used.During use, while sewing the skin, the suture pulled off the needle.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: was the needle piece removed from the patient? unknown.Patient condition? the patient was in good condition.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.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/9/2022.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 to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that an opened sample of product code vcp441h was received for evaluation.The visual inspection concluded that in the detached needle, the swage and attachment area was noted to be as expected and no suture remnant could be observed at the barrel hole, and the shape of the barrel shows there isn¿t enough impression, resulting in a needle pull off defect.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This defect is caused when does not tighten the press correctly and the swage area is weak on the needle/suture this product issue will be addressed through ethicon quality system.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.

• Brand Name: VCL+ UD 27IN 4-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. - BRAZIL; rodovia presidente; dutra km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14047405
• Report Number: 2210968-2022-02490
• Device Sequence Number: 4791894
• Product Code: GAM
• UDI-Device Identifier: 10705031053274
• UDI-Public: 10705031053274
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: VCP441H
• Device Catalogue Number: VCP441H
• Device Lot Number: PJ4659
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female