MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.When the doctor was suturing, the needle broke off.There were no reported adverse patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not received.Additional information provided: 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: was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, additional information has been requested however not received.Attempts to obtain the product sample have been made.If further details are received at a later date a supplemental medwatch will be sent.Could you please clarify if the patient suffered from any signs or consequences due to the issue (breakage needle)? please provide more information.What is the lot number? please perform and document the follow up attempt for product return.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.

• Brand Name: VCL CT BRD VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16876757
• Report Number: 2210968-2023-03328
• Device Sequence Number: 15269358
• Product Code: GAM
• UDI-Device Identifier: 10705031038912
• UDI-Public: 10705031038912
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 05/05/2023

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 Model Number: J333H
• Device Catalogue Number: J333H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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