As reported, the bard soft mesh pre-shaped tore during implant.The subject device was not returned for evaluation, however a photo was provided.Evaluation of the photo finds that the surgeon tailored the mesh creating a v shape which shows cutting from the edges inward and then pulling of the mesh into the v shape.It also appears the doctor created a keyhole above the v shape of the mesh.Based on the photo evaluation and investigation performed, the mesh tearing cannot be confirmed as the mesh was tailored for use.Hence, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2020.The instructions-for-use (ifu) supplied with the mesh adequately describes the proper technique for implantation.The precautions section of the ifu states, "intact bard soft mesh exhibits high burst and tensile strength.However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point." not returned.
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As reported, during lichtenstein herniorrhaphy on (b)(6) 2022, the bard soft mesh was attempted to implant into the patient.As reported, the surgeon tried to pick the mesh up and the mesh broke with a hole just with a finger under it.It was also reported that there was no tear/hole on the mesh identified when opening the package or prior to insertion into the patient.As reported, the surgeon used another bard soft mesh to complete the procedure and there was no reported patient injury.
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