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It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During the procedure, it was reported that surgeon complained of vicryl suture was unintentionally popping off of the needle.Additionally, surgeon complained that suture itself was unintentionally breaking and not as strong as normal.Patient consequences unknown.Surgical delay unknown.There were no adverse consequences reported.Additional information was requested.
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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, 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.H3 investigation summary: the product was returned to ethicon for evaluation.Two open box with a quantity of sixteen samples were received for analysis.Product code vcp495g.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 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 the 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.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.If possible, please confirm the number of sutures that "broke" and the number of sutures that "pop off" from the needle during this procedure.When did the sutures pop off/break (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? please specify for each of the involved devices.Were there any patient consequences? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).H3 investigation summary: the product was returned to ethicon for evaluation.Two open box with a quantity of sixteen samples were received for analysis.Product code vcp495g.As per the sampling plan, a visual inspection was performed on thirteen samples, the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.A functional test was performed using instron equipment and the tensile force was 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.
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