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Product complaint # (b)(4).Date sent to the fda: 4/3/2025 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.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.One detached needle outside its packaging was received for analysis.Product code vcpb864d.Upon initial inspection of the samples, no external damages were observed on the external packets.The visual assessment of the needle, the swage, and attachment area were noted to be as expected.The tip and body of the needle was examined under magnification and no defects or needle breakage were found.The sample was tested by resistance test to the needle and met the requirements.The needles were noted to be the corresponding blunt point ethiguard needle for the vcpb864d product code.No damages or needle deformation were observed during the visual inspection.The needles were passed through a tissue simulator and no abnormalities were noted.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as 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.Additional h3 investigational summary: the product received for analysis was vcpb864d.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Visual inspection and metallurgical analysis were performed on the returned product.A blunt tip was observed.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the needle contained a blunt tip.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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It was reported that a patient underwent an orthopedic procedure on an unknown date and suture was used.During an unknown orthopedic surgery, the suturing was not smoothly when dermis suturing was performed (single nodule, and not instrument tying), so when the needle tip was checked, it was not sharp.There is a possibility that the needle tip had been broken.It was confirmed that it was not in the patient's body after surgery.It was a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
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