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

Model Number	J334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/20/2023.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: did the needle fall into the patient? yes.If yes, was the needle piece(s) retrieved during the same procedure? yes.Were x-rays taken to locate the needle piece(s)? not required.What measures were taken to retrieve the broken piece? used forceps and needle driver.Was there any additional tissue damage as a result of searching for the needle piece? no.Does a piece of the needle remain in the patient¿s tissue? if yes, is there any plan in place to remove the needle piece in the future? n/a.If yes, please provide the scheduled date.N/a.What tissue structure the broken needle was located? information not.What is the surgeon's opinion of consequences to the patient? no consequence.Device return status.Please document the shipment tracking number: available.Tracking number to follow.Please provide the source or name of person providing answers to follow-up questions.(b)(6).The following additional information was received: was surgery delayed due to the reported event? --> no, action taken when event occurred? --> opened another suture for closure, was procedure successfully completed? --> yes, were fragments generated? --> yes, if yes, were they removed easily without additional intervention? --> yes, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown 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.
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on (b)(6) 2023 and suture was used.During use on the patient it was noted when suturing closed an incision, tip of the needle broke off.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(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.Additional h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received twenty-seven unopened samples that pertain to product code j334h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened.The swage and attachment area was noted to be as expected.The tip and body of the needles were examined under magnification and no defects or needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The device performed without any difficulties noted.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 27IN 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.-SAN ANGELO; 3348 pulliam st; san angelo 76905 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17367274
• Report Number: 2210968-2023-05269
• Device Sequence Number: 7361835
• Product Code: GAM
• UDI-Device Identifier: 10705031038936
• UDI-Public: 10705031038936
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/26/2023

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: J334H
• Device Catalogue Number: J334H
• Device Lot Number: TA2ALZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2023
• 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