MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 27"(70CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR426
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The suture was used to sew skin and broke during surgery.The surgery prolonged about 1 hour since suture breakage occurred several times.The patient is stable now.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Therefore, (01) gtin is not available.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: after investigation, the patient underwent general surgery in the hospital on (b)(6) 2025 (the specific patient's diagnosis and procedure name were unknown.Then, a new suture (with specific product information unknown) was replaced to complete the skin suturing.Did this issue contribute to any patient adverse event? no subsequent adverse event reports were received.How many devices demonstrated the alleged deficiency? suture breakage occurred several times during suturing (the specific number of times was unknown).Were there any unexpected outcomes or complications resulting from the prolonged surgery time? no subsequent adverse event reports were received.How long, in minutes, did the surgery prolong? this event resulted in an extension of the surgery time by about one hour.Which tissue was being sutured when the event occurred? the surgeon used suture (vr426) to perform the skin tissue suturing in an interrupted suture manner during the surgery.The following information was requested, but unavailable: was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post-operative care due to the prolonged procedure? what is current condition of the patient? 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, 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: 2/20/2026.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, 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: g07002 no device problem found.Additional information: d9, h3, h6.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.The returned product determined that it was received one open box with fifteen (15) unopened samples pertain to the product code vr426.As per the sampling plan, a visual inspection was performed on thirteen samples, no defects were found on the packages.The packets were open, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no issue related to breakage sutures were observed during evaluation.Also, a functional test was performed using an instron equipment and tensile force were above the minimum requirements.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the devices performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VICRYL RAPIDE SUTURE 27"(70CM) 4-0 UND
• 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 paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24131601
• Report Number: 2210968-2026-00759
• Device Sequence Number: 5455973
• Product Code: GAM
• UDI-Device Identifier: 10705031134669
• UDI-Public: (01)10705031134669(17)300331(10)AW5518
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033746
• 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
• Report Date (Section B): 01/21/2026

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 Catalogue Number: VR426
• Device Lot Number: AW5518
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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