Medical Device Material Torqued

Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material (Food and Drug Administration)

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Medical Device Material Split

Issue associated with a partial or full-thickness crack in the device materials.

Medical Device Material Separation

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

Medical Device Material Rupture

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

Medical Device Material Puncture

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

Medical Device Material Perforation

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

Medical Device Material Integrity Issue

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