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Product complaint # (b)(4).Date sent to the fda: 3/6/2026.H6 component code: g07002 - pending evaluation of returned device.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-conformances were identified.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: please confirm if the needle broke into separate pieces or if the entire needle detached from the suture.Did any needle piece fell inside of the patient? if yes, was it retrieved during the same procedure? what efforts were made to retrieve it? please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager) a device has been received; however, it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Product complaint # (b)(4).Date sent to the fda: 4/7/2026.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.H6 component code: g07002 no device problem found.Additional information: d4, d9, h3, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Two sealed boxes containing twelve representative unopened samples each (24 total), and two opened boxes containing four and eleven representative unopened samples, respectively (15 total), for an overall total of 39 samples received for analysis.Product code 1864g.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen (13) samples, the packets were opened, and the swage and attachment area were noted to be as expected.The tip and body of the needles were examined under magnification, and no defects or needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.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.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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