Reason/Issue |
Laser marking location is out of specification (i.e., greater than 2.00 inches from the distal end of the cutting burr). Fracture of the carbide cutting bur could occur if short cutting burrs with an out of specification laser location were used with an attachment that may have worn bearings. Cutter fracture could result in user laceration, re-operation due to remaining fragments, soft tissue damage due to fragment retrieval, and delay in surgery. |