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Product complaint#: (b)(4).Date sent to the fda: 1/13/2025.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, or its employees that the report constitutes an admission that the product, ethicon, 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-conformance's were identified.The single complaint was reported with multiple events.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: it was reported that "the needle was not performing normally", please provide more details: what is the total number of procedures where the suture broke and the needle was not performing normally? please provide the product code and lot number of these products: have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the source or name of person providing answers to follow-up questions: h3 investigational summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.In order to evaluate the condition of the returned sample, the packaging was opened.No defects were detected on the product; the swage and attachment area was noted to be as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during evaluation.The returned needle was noted to be the corresponding prime reverse cutting needle for the j495g product code.No damages or needle deformation were observed during the visual inspection.The needle was passed through a tissue simulator and no abnormalities were noted.The functional test was performed using an instron equipment and tensile force were above the minimum requirements.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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