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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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-conformances were identified.Additional information was requested, and the following was obtained via: did this issue contribute to any patient adverse event? when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Please perform and document the follow up attempt for product return.Please provide tracking number.1- no.2- use on the patient.3- eg (please refer to the attached email).4- please ship a return box to account now.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that used needle was received for analysis.Product code vcp958.During visual inspection of the needle.Marks were noted at the edge of the swage area.The barrel hole was examined, and one little suture piece was still attached to the needle.Besides that, the suture piece was noted to be cut probably caused by a surgical instrument.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that four (4) unopened samples were received for analysis.Product code vcp958h.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of eth 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.
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It was reported that a patient underwent a c-section procedure in 2026 and suture was used.During the procedure, it was reported to the sales rep that during a procedure, three sutures broke intraoperatively just below the swage.The sutures behaved like a pop-off and broke at the top when the surgeon passed them through the tissue during approximation at the end of the procedure.No adverse patient consequences were reported.Additional information was requested.
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