MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS VIO 90CM M3 USP2/0 SGLE ARMED CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	VCP1345H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 9/18/2025.H6: component code: g07002 - pending evaluation for returned device.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-conformance's were identified.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.It was reported that the needle broke when sewing in surgery.Changed another one to continue the surgery, the suture broke.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
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, d9, h3.H3 investigation summary: a failed suture needle, labeled as (b)(4), was submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on september 22, 2025.The component was identified as product code vcp1345h.It was requested that hsa assess the fracture mode of the failure.According to the information, it was reported breakage suture.The product received for analysis was vcp1345h visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was mixed mode with transgranular cleavage and (b)(4) coalescence.This was a mixed mode fracture.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows two open foils labeled as vcp1345 lot# s25020110 expiration date 2019-02-19 and an empty winding former.The image is not clear to determine the failure mode or the reported condition.Based on the photo review, the event reported is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.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, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.One paper lid, one foil packet and one winding former both were empty were received for analysis.Product code vcp1345h.The visual assessment of the returned sample.The suture was not returned for analysis.As per this condition, the event described could not be confirmed.If additional information is made available, the investigation will be updated as applicable.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: VICRYL PLUS VIO 90CM M3 USP2/0 SGLE ARMED CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; suzhou 21512 6; CH 215126
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23087612
• Report Number: 2210968-2025-10690
• Device Sequence Number: 16079366
• Product Code: GAM
• UDI-Device Identifier: 10705031236530
• UDI-Public: (01)10705031236530(17)300218(10)S25020110
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181652
• 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): 11/11/2025

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: VCP1345H
• Device Lot Number: S25020110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 11/10/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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