An altis sling was received for evaluation.Examination of the sling revealed the static anchor detached from the mesh and not received.Visual observation of the mesh where the static suture was attached confirmed the welded area of the suture was still attached.Microscopic examination of the static suture where the anchor had detached revealed rough and irregular surfaces, indicating stress may have been exerted.The dynamic suture was still attached to the mesh as received, along with the dynamic anchor & tensioner.Blood residue was noted on the mesh.The information received indicated the static anchor detached during implant.Quality confirmed the detached static anchor.As the static anchor was not received, it was concluded that the detachment of the static anchor most likely occurred during the tensioning part of the procedure.As the detachment ends of the static suture were rough and irregular, this indicated that excess stress most likely exerted to result in the separation noted.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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