MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 1 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J353H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
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.(b)(4).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.Device return status: what is the total number of products involved in this event? 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, provide the respective reference number(s).Lot#: at1161 is not a valid lot number.Please provide a valid lot number.It was reported that previous notifications have been made for other wires.Please provide pc#s for previous reports.If none, please add 1 pc for each complaint.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.The thread broke during the surgical procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/10/2023.The following devices have been received, however clarification is requested whether the products belong to this complaint.Product code j353; lot at1123; product code j353; lot at1151; product code j353; lot ar8573; product code j371; lot at4257.The following additional information was requested: our failure analysis lab received the additional product with reference to this complaint, the following products were received: product code j353; lot at1123; product code j353; lot at1151; product code j353; lot ar8573; product code j371; lot at4257.This complaint is for product code product code: j353, lot at1161.Could you please clarify if the additional devices belong to this complaint? if yes, did a device malfunction occur during the same procedure? if not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.If the device was not reported before, please provide more details of device malfunction.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to (b)(4) with the ups, dhl or fedex tracker number.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 1 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao poalo 12240 -908; BR 12240-908
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16038695
• Report Number: 2210968-2022-10587
• Device Sequence Number: 12173250
• Product Code: GAM
• UDI-Device Identifier: 10705031039209
• UDI-Public: 10705031039209
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: J353H
• Device Catalogue Number: J353H
• Device Lot Number: AT1161
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/10/2023
• 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