MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	J946H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg procedure in 2026 and suture was used.During the procedure, it was reported that 0 vicryl j946 was used in closing fascia in an add on cesarean section with surgeon.A part of the needle broke off from the main needle and suture.It was located but needle was then in two pieces.They said its happened a few times.Surgical delay was unknown.No patient harm was reported.No adverse patient consequences were 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.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.Could you please provide the lot number? could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided.Please provide the source or name of person providing answers to follow-up questions: the manufacturing records could not be reviewed as the batch/lot number is unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional h11: we received this report: 0 vicryl j946 was used in closing fascia in an add on cesarean section with dr (b)(6), assist dr (b)(6).A part of the needle broke off from the main needle and suture.It was located but needle was then in two pieces.Lot number 10a95g they said its happened a few times.Was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no patient involvement, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4), device property of none, device in possession of none.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d 4.Lot, d 4.Expiration date, g 1.Manufacturer site postal code, h4.Device manufacture date, h6.Type of investigation.Corrected information: d 4.Primary udi number, g 1.Manufacturing site name, g 1.Manufacturer site addr.Street line 1, g 1.Manufacturer site city, g 1.Manufacturer site country code.Additional information was requested, and the following was obtained: could you please provide the lot number?0 vicryl j946 lot # 10a95g.How many devices demonstrated the alleged deficiency? 1.Did the event occur during one or multiple patient procedures? no.What is the total number of procedures? 1.Have any of these events been previously reported to ethicon? if so, could you please.Provide the corresponding reference number(s)? none of this type.A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.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.

• Brand Name: VCL CT BRD UD 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24238192
• Report Number: 2210968-2026-01222
• Device Sequence Number: 8970729
• Product Code: GAM
• UDI-Device Identifier: 10705031043671
• UDI-Public: (01)10705031043671(17)300731(10)10A95G
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: J946H
• Device Lot Number: 10A95G
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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