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It was reported that a patient underwent an unknown procedure in 2026 and suture was used.During the procedure, it was reported to the dl by the sales rep that during closure, two needles broke during use.There is no adverse impact patient/user reported.Device is available for return.No adverse patient consequences were reported.Additional information was requested.
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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 the needle fall into the patient? if yes: was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? does a piece of the needle remain in the patient¿s tissue? if yes: is there any plan in place to remove the needle piece in the future? if yes, please provide the scheduled date.What tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager) please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Both broken needles and the suture box with the remaining sutures from the same lot number have been shipped to be analyzed.The needles did not fall into the patient.They were used for closing at the skin layer (subcuticular).Both needles are in a specimen container and appear to be intact but the customer claims that those needles both broke.All parts of the needle are within the specimen container).Surgeon did not provide an opinion and is not concerned.The tech during the case reported the broken sutures to the materials department who then notified me.The tech was not available for follow up questions and did not provide any additional details.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one open box with thirty (30) unopened samples were received for analysis.Product code mcp935h.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were opened and the swage and attachment area were noted as expected.The tip and body of the needles were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.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 eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.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 investigation summary : the product was returned to eth for evaluation.Visual inspection revealed that one used needle suture piece was received for analysis.Product code mcp935h.During the visual inspection of the returned sample the swage and attachment area were noted as expected.The tip and body of the needle were examined under magnification and no anomalies or issues related to needle breakage were found.However, crimping marks likely caused by a surgical instrument could be observed in the needle.In addition, the sample was tested by resistance test to needle and met the requirements.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 eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.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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