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Product complaint # (b)(4) date sent to the fda: 12/1/2025.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.Additional information was requested, the following was obtained: 1.How long was the delay? please specify in minutes.The estimated additional surgery time related to the event was about 2 minutes.2.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? there were no complications or adverse outcomes to the patient as a result of the prolonged surgery time.The patient is doing very well post-operatively.3.What is the source of information for the queries above (e.G., answered by the physician / provided from knowledge as you were present in the case) the above information was provided by the cardiothoracic surgeon who performed the procedure.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was reported: if other, describe while anastomosis in the cabg procedure, was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? patient remained stable with no adverse clinical outcome, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4), device property of hospital, device in possession of (b)(6).
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It was reported that a patient underwent a cabg procedure on (b)(6) 2025 and suture was used.During a coronary artery bypass graft (cabg) procedure, the suture snapped in the middle of the anastomosis.A total of three (3) sutures were used, all of which experienced breakage during use.Additionally, the needle was observed to bend while being held with the needle holder.The surgeon managed to complete the anastomosis despite the repeated suture snapping and needle deformation.The incident caused procedural delay and inconvenience to the surgical team.There were no patient consequences reported.Additional information was requested.
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