Medical Device Material Split

Issue associated with an undesired disassociation or breaking apart of device materials.

Issue associated with the bursting or tearing apart of a material.

Issue associated with the comprising material(s) being penetrated, pierced or punctured, especially with a sharp or pointed object.

Issue associated with an undesired material damage characterized by closely spaced punched or drilled holes.

Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the…

Issue associated with small pieces of the device breaking off unexpectedly.