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)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002: device not returned.Additional information provided: this was done with several threads from 3-4 bx of the same batch.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Unfortunately, i could not get any further and more detailed information in the hospital, as the incidents (except for the last one, here a day later) were longer back before i received the information.How many devices demonstrated the alleged deficiency? could you kindly provide the lot number of each device, please? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? it was reported that "once the needle broke without excessive force" did the needle broke during the same surgery? was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were implemented to retrieve the broken piece? was there any additional tissue damage resulting from the search for the needle piece? what is the surgeon's opinion of the potential consequences for the patient? could you kindly confirm the product code and lot number of each device, please? it was reported that "this was done with several threads from 3-4 bx of the same batch".Please confirm the specific outcomes for each device: could you kindly confirm the product code and lot number of each device, please? could you kindly perform and document the follow-up attempt for the product return please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.No product is available for return.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.
Event or Problem Description
It was reported a patient underwent an open gynecological procedure on an unknown date in 2025 and suture was used.The needle had detached directly from the suture without strong traction when pulling through the tissue.The operation was continued and completed as planned using sutures from a different batch.No patient harm nor significant delay reported.No used sutures were retained, but discarded directly intra-operatively.Additional information has been requested.

• 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.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21457810
• Report Number: 2210968-2025-02048
• Device Sequence Number: 12809255
• Product Code: GAM
• UDI-Device Identifier: 10705031039117
• UDI-Public: (01)10705031039117(17)300303(10)ULBCLGZ0
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 02/25/2025

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: ULBCLGZ0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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