MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 4X27IN 2 S/A TP-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J649G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent unspecified plastic surgery on (b)(6) 2023 and suture was used.The needles kept popping off when the surgeon would try to penetrate through tissue.There were no adverse patient consequences.No further information was provided.
Additional Manufacturer Narrative
Product complaint (b)(4).H6 component code: g07002 - no device problem found.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: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received, one unopened sample that pertain to the product code j649g.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted to be as expected.The suture was 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.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional information was requested and the following was obtained: 1.Could you please clarify if the additional device belong to this complaint? 1a.If yes, did a device malfunction occur during the same procedure? it was reported that each suture in the open box was part of the same complaint.J649g was reported to also have an issue with needle popping off after passing through tissue and approximating.2.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.3.If the device was not reported before, please provide more details of device malfunction.It was reported that each device that was collected and returned had an issue with the needle popping off prematurely.No patient consequences.4.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.Additional information was requested, the following was obtained: 1.Could you please clarify if the additional device belong to this complaint? 1a.If yes, did a device malfunction occur during the same procedure? yes, the same issue occurred with j649g when passing suture through tissue, needle was popping off prematurely a manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Related reports: 2210968-2023-06697, 2210968-2023-06698 , 2210968-2023-06699, 2210968-2023-07662, 2210968-2023-07663, & 2210968-2023-07664.

• Brand Name: VCL CT BRD VIO 4X27IN 2 S/A TP-1
• 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 ; 9083863534
• MDR Report Key: 18518433
• Report Number: 2210968-2024-00397
• Device Sequence Number: 6751327
• Product Code: GAM
• UDI-Device Identifier: 10705031042018
• UDI-Public: 10705031042018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/16/2024

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 Catalogue Number: J649G
• Device Lot Number: TBMCZP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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