MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/15/2025.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.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: it was reported that the suture repeatedly broken.How many devices demonstrated the alleged deficiency? 1.Did the reported issue contribute to any patient adverse consequences? no.Could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.No device can be returned.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.
Event or Problem Description
It was reported that a patient underwent a delivery surgery on (b)(6) 2025 and suture was used.The pregnant woman stopped menstruating for 38w, had vaginal redness for 1 day, and had vaginal fluid flow for more than 1 hour before being admitted at 15:41.The admission diagnosis was: 1.Premature rupture of membranes.2.Pregnancy complicated with hypothyroidism.3.Pregnant at 38 weeks.4.Pregnant 5 times.5.Produce twice.6.Pregnancy supervision for elderly multiparous women.7.The umbilical cord wraps around the neck once.21:42 delivery, perineal i degree laceration after delivery, sutured with suture.During the suturing process, the suture was gently pulled and repeatedly broken.After replacing the suture, the suturing is completed.Before the patient leaves the clinic, the doctor rechecks the wound for any broken sutures or active bleeding caused by loose sutures.There were no patient consequences reported.Additional information was requested.

• Brand Name: VICRYL RAPIDE SUTURE 36"(90CM) 2-0 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: 23802042
• Report Number: 2210968-2025-14014
• Device Sequence Number: 18459179
• Product Code: GAM
• UDI-Device Identifier: 10705031134768
• UDI-Public: (01)10705031134768(17)290930(10)AW0910
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: VR917
• Device Lot Number: AW0910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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