Important Safety Alerts

Medical device manufacturer, DePuy (a Johnson & Johnson company) has initiated a medical device field safety corrective action concerning Specialist 2 Intramedullary Rod (SP2 IM Rod)(part number966120).

DePuy has identified the potential for the SP2 IM Rod to fail due to fatigue when excess leverage is applied at the tip. There is a deep J shaped groove at the tip of the rod, which allows a sleeve to lock into place when used in revision cases. It is at the top of this groove that fracture can occur. DePuy has received 9 complaints since 2008 regarding the tip breaking with 8 complaints where the tip was left in the patient.

In remote circumstances, the possible clinical implications related to the SP2 IM Rods fracturing with tips left in the patient include:

• Significant surgical delay due to attempted retrieval of remaining fragments
• Minor bone damage due to attempted retrieval of remaining fragments
• Adverse tissue reaction
• Pain due to potential bone remodeling or during Magnetic Resonance Imaging

Due to the potential for the rod to break, leaving fragments in the patient, a field safety notice was sent out to the affected users to provide additional information on how to use the SP2 IM rods to minimize the potential for breakage. In additional, DePuy is currently investigating a material change to the rod to reduce the possibility of the tip fracturing.Changes have/will be made to the surgical techniques to include the guidance below.

DePuy would like to emphasize several technical points regarding the use of the rod that may further reduce the incidence of tip fracture:

1. Avoid using excessive force to drive the rod into the IM canal. If a large amount of force is required to insert the rod, the femoral canal may be overly bowed, or the distal entry hole may be too tight to permit the rod to center in the canal. Should this be encountered, using a shorter IM rod may be more appropriate. Enlarging the distal entry hole may help as well. n
2. The rod tip is much stronger when the sleeve slot is in compression. This can be achieved by making sure the slot on the modular handle (the landmark for locking the rod to the handle) is facing medially when the rod is inserted on a right knee, or laterally on a left knee. n
3. Do not use the rod as a slap hammer to remove a well-fixed SP2 distal femoral locating device. This can lead to high stress concentrations in the rod tip. If set pins are well-fixed to the distal femur, use a ronjeur to release the set pins.
4. The rod should not be used as a femoral distractor to pull the femur away from the tibia. In lieu, use a bone hook or use a U-shaped retractor.
5. Check the condition of the rod on a regular basis. Return any rods showing signs of cracks in the distal tip near the sleeve groove.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 6 March 2013