MDR - Biomet Cannulated Screws

Inclusion Criteria:

• Patient must be 18 years of age or older.

All patients operated on for the following indications:

• Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for usein:

1. Fixation of small bones, including those in the foot, patella, ankle, wrist andelbow.

2. Arthrodesis of the foot, wrist and elbow.

3. Small and long bone osteotomies.

4. Fracture fixation of small bones, small bone fragments and long bones.

• Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for usein:

1. Fixation of fractures in long bones and long bone fragments.

2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).

3. Arthrodesis and fracture fixation of the foot and ankle, such as Jonesfractures of the fifth metatarsal, and Calcaneal fractures.

• Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for usein:

1. Slipped capital femoral epiphysis

2. Pediatric femoral neck fractures

3. Tibial plateau fractures

4. SI joint disruptions

5. Intercondylar femur fractures

6. Subtalar arthrodesis

7. Fixation of pelvis and iliosacral joint

• Patients must have the ability and willingness to follow instructions, includingcontrol of weight and activity levels.

• Patient must have a good nutritional state.

Exclusion Criteria:

• Infections.

• Patient conditions including blood supply limitations, insufficient quantity orquality of bone.

• Patients with mental or neurologic conditions who are unwilling or incapable fofollowing postoperative care instructions.

• Foreign body sensitivity where material sensitivity is suspected or unknown, testingis to be completed prior to implantation of the device.

• Patient is a prisoner.

• Patient is a current alcohol or drug abuser.

• Patient is known to be pregnant or breastfeeding.

• Patient has a psychiatric illness or cognitive deficit that will not allow forproper informed consent.