MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J258H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unspecified ob procedure on an unknown date in (b)(6) 2023 and suture was used.During the procedure, two needles snapped off at the suture.The needles did not break, but detached from the suture.There were no adverse consequences for the patient.No further information was provided.
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.The device(s) upon which this medwatch is based have been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Related events captured via 2210968-2023-03477.
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.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received one sealed box with thirty-six unopened samples that pertain to the product code j258h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related events captured via 2210968-2023-03477.

• Brand Name: VCL CT BRD UD 27IN 3-0 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.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16896843
• Report Number: 2210968-2023-03478
• Device Sequence Number: 6312114
• Product Code: GAM
• UDI-Device Identifier: 10705031038295
• UDI-Public: 10705031038295
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: J258H
• Device Catalogue Number: J258H
• Device Lot Number: SBMCXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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