Medical Device Model Family

Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents.

Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.

Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material

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

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

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