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

Catalog Number	J346H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was reported by a sales rep that, during an unknown surgery, the suture was detached from the needle.It was not a control release needle.Another product was used to complete the case.When we send the sample to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested, and the following was obtained via: *can you identify the lot number of the product used? unk.*please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep): (b)(6).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.-lot number of ip-02347286: unk: 103l2a.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/11/2025.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.Additional information: d4, d9, h3, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One empty labeled winding former, one detached needle and one suture piece were received for analysis.During the visual inspection of the sample, the swage area and the edge were noted with marks probably caused by a surgical instrument.Furthermore, a small portion of the suture to be still attached to the barrel hole.The suture piece received was inspected, and the extremes were noted to be cut probably caused by a surgical instrument.On one extreme was noted fraying since a filament of the suture was pulled, and the strand was twisted.The condition of the sample received indicates improper handling of the device.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL CT BRD VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 21904099
• Report Number: 2210968-2025-04507
• Device Sequence Number: 8623459
• Product Code: GAM
• UDI-Device Identifier: 10705031039117
• UDI-Public: (01)10705031039117(17)290831(10)103L2A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: J346H
• Device Lot Number: 103L2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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