MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	J359
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint :(b)(4).Date sent to the fda: 5/12/2025.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, 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.(b)(4): the thread broke twice.- were there any adverse consequences associated with the patient? no patient consequences.- when was the thread broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify: during use on the patient.(b)(4): represents the ambiguous number of events.- were there any adverse consequences associated with the patient? no patient consequences, use of a third suture.- what is the total number of procedures? several cases of breakage (needle or detachment of the thread) recently (case on (b)(6) 2024, two cases on (b)(6) 2025) and each time with vicryl but from different references, but no breakage of the thread yet.The pharmacist has no additional information.The doctor who noted the defect is absent until may and will get back to us with a more detailed description of the facts the two cases on february 2025 are (b)(4) and the case on (b)(6) 2024 is (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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.The following information was requested: the reported lot udbcznhd0 is invalid, please confirm the lot number.
Event or Problem Description
It was reported that a patient underwent an c-section procedure on (b)(6) 2025 and suture was used.A surgical nurse "ibode" reported a quality defect regarding the use of a suture.During a uterine suture following a cesarean section using vicryl 1, the thread broke twice.This is not the first time this has happened.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/10/2025.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.Corrected information: d4 (lot).The following information was requested: the correct lot n° is udbczhd0.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/8/2025 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.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22004826
• Report Number: 2210968-2025-05228
• Device Sequence Number: 13040201
• Product Code: GAM
• UDI-Device Identifier: 10705031039278
• UDI-Public: 10705031039278
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022269
• 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,Followup
• Report Date (Section B): 05/12/2025

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: J359
• Device Lot Number: UDBCZHD0
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/12/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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