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	Hematoma (1884)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a salpingectomy laparoscopy, bilateral hysteroscopy with ablation tissue, hysteroscopy dilatation and curettage wi surgical procedure in (b)(6) 2024 and suture was used.During the procedure, per user facility medwatch form, #(b)(4), salpingectomy laparoscopy, bilateral hysteroscopy with ablation tissue, hysteroscopy dilatation and curretage wi surgical procedure was concluded, surgeon was suturing the incision sites.Preferred suture is being replaced, and the new one was used.While suturing the incision site, the suture thread broke multiple times.Surgeon was unsatisfied with the replacement suture.He believes the break in the suture may have caused a hematoma.Device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4) h6 component code: g07002 - device not returned 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that ".While suturing the incision site, the suture thread broke multiple times.Surgeon was unsatisfied with the replacement suture.He believes the break in the suture may have caused a hematoma" please confirm the number of sutures that broke during this procedure.How was the hematoma treated? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescription strength.Were there any unexpected outcomes, complications, or changes in the patient¿s postoperative care due to the hematoma? were there any patient consequences? is this device or samples from same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) please provide the source or name and title of the external person providing answers to follow-up.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information: h6.Additional information was requested, and the following was obtained via: * please provide the source or name and title of the external person providing answers to follow-up.See info in signature line.Corrected data: d3 mfr email.

• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20473017
• Report Number: 2210968-2024-10818
• Device Sequence Number: 18022302
• Product Code: GAM
• UDI-Device Identifier: 10705031134669
• UDI-Public: (01)10705031134669(17)280829(10)AU9239
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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: VR426
• Device Lot Number: AU9239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 05/15/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/08/2024; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 89 KG