MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 4-0 S/A C-3; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J386H
Medical Device Problem Code	Break (1069)
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 procedure on an unknown date and suture was used.During the procedure, the needle has been breaking, they have had three break within the last two days.They have used this brand for the last several years with no issues but this is obviously a safety concern for them.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4) date sent to the fda: 2/6/2024 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 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: please confirm the number of procedures affected by this issue.When did the needle break (in the package, during removal from the package, during handling before use on patient or during use on the patient)? did any piece fall into the patient? if yes, what was done to retrieve the broken piece? for example, another incision, second surgery? were there any patient consequences? to whom should the replacement be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number a prepaid fedex label has been provided via email to return the remaining sutures from this lot for analysis.Please confirm the quantity to be returned and when will the device be sent.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) 1.2 procedures were affected.2.Needle broke during use on patient all three times.3.The needle did fall but it was retrieved.Patient was under sedation and had a throat pack in.4.No consequences to the patient.5.Address to send replacement : (b)(6) 6.6 sutures will be sent back.I will send them out today if i am provided with the fedex label by email today.I don't see it attached.7.My name is (b)(6) - title efda,cp & clinical lead 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.Related reports: 2210968-2024-00989, & 2210968-2024-00992.

• Brand Name: VCL CT BRD VIO 18IN 4-0 S/A C-3
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18651843
• Report Number: 2210968-2024-00990
• Device Sequence Number: 7256270
• Product Code: GAM
• UDI-Device Identifier: 10705031039490
• UDI-Public: 10705031039490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: J386H
• Device Lot Number: QAMCHH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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