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DePuy issues field safety notice for Specialist 2 Intramedullary Rod
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DePuy Orthopaedics Inc. issued a field safety notice for certain lot numbers in its line of Specialist 2 Intramedullary Rod products after several complaints of the rod tips fracturing, leaving fragments in the patient.
“The purpose of the [February 2013] correction notice was to provide surgeons with additional information on how to use the [Specialist 2 Intramedullary Rod] SP2 IM rods to minimize the potential for breakage,” Mindy Tinsley, director of worldwide communications at DePuy Synthes Joint Reconstruction, told Orthopedics Today. “In its communication to surgeons, DePuy emphasized several technical points regarding the use of the rod that may further reduce the incidence of tip fracture.”
Used in both primary and revision Sigma knee total knee replacements, the SP2 IM helps align the femoral locating device, the distal femoral cutting block and is also used with the IM tibial resection, according to the field safety notice. Tinsley said approximately 2,600 SP2 IM rods sold in the United States since 2008 are affected by the notice, which was also sent to more than 50 countries outside the United States.
To minimize the tip of the rod fracturing during total knee replacement, DePuy recommended surgeons take the following precautions:
- avoid using excessive force to drive the rod in to the IM canal, or using a smaller rod if a large amount of force is required;
- strengthen the rod tip by making sure the sleeve slot on the modular handle is facing medially when the rod is inserted in a right knee, laterally in a left knee;
- do not use the rod as a slap hammer to remove a well-fixed SP2 distal femoral locating device;
- do not use the rod as a femoral distract to pull the femur away from the tibia; and
- check the condition of the rod on a regular basis, and return any rods showing signs of rack in the distal tip near the sleeve groove.
In the notice, DePuy stated that possible implications of the rod fracturing inside the patient include significant surgical delay and/or minor bone damage in retrieving the fragments, adverse tissue reaction and pain due to potential bone remodeling or MRI.
Surgeons interested in the full list of lot numbers listed in the field safety notice can click here.
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