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It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used.The surgeon placed the first stitch and pulled the suture through the tissue.Due to the arrangement of the barbs on the suture, a noticeable resistance should normally be felt at the midpoint.However, the suture passed through the tissue without any difficulty and without catching.The surgeon then checked whether the barbs were present and commented that they were barely perceptible.A second suture was opened, and the barbs were compared again.According to the reporter, the product has deteriorated since the switch from sxpd2b400, and the barbs are noticeably less pronounced than before.No adverse patient consequences were reported.Additional information was requested.
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Product complaint # (b)(4).Additional information was requested, and the following was obtained:
was there any reported patient or user harm? no.Was there a significant delay? no.Could you please confirm whether the second suture was used on the patient? confirmed, the second suture was used on the patient
could you please confirm how many of the 9 reported products, other than the first suture, were used on the patient? 2 of the 9 sutures were used on the patient.The first was removed; the second implanted.7 more suture were unopened in the suture box.How was the procedure completed? procedure was completed normally.What was the procedure performed? total hip replacement cementless.What is the product return status? available.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Surgeon.H3 b03 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that seven unopened samples were received for analysis.Product code sxpp2b400.Upon initial inspection, no external damages were observed on the packets.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand and no anomalies were observed during evaluation.Ten barbs were measured in the strands, and all barbs met the 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.H3 b01 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one dispensed used needle suture combination, one winding former with one used needles suture and one empty foil packet were received for analysis.Product code sxpp2b400.During visual inspection, the swage and attachment area were noted to be as expected in all needles.The sutures were examined, and body fluids were noted along strands.Per the condition of the sample, the barbs could not be measured, and the end was observed to be cut probably by a surgical instrument.As part of the eth quality process, all devices are manufactured, inspected, and released to approved specifications.Given the current condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Device history review: a manufacturing record evaluation was performed for the finished device batch 10gk59, sxpp2b400-14 and no non-conformances were identified.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.
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