A Class 1 recall for the DePuy Synthes’ Small Battery Drive and the Small Battery Drive II adaptor and light adaptor has been announced by the U.S. Food and Drug Administration (FDA). The adaptors potentially produce extreme internal pressure that may cause the device to explode causing severe adverse health problems. A Class 1 designation is the FDA’s most serious, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The DePuy Synthes Company is known for its comprehensive portfolio of orthopedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, and cranio-maxillofacial procedures, as well as surgical power tools and biomaterials.
The Johnson & Johnson subsidiary, DePuy Synthes, sent an “Urgent Notice-Medical Device Recall” letter to all customers affected by the Class 1 recall. DePuy Synthes’ customers are hospitals and surgical center facilities. According to the FDA, the recall notice that led to the Class 1 designation stated that the “Urgent Notice-Medical Device Recall” notice should be kept visibly posted for awareness.
Issues Associated with the DePuy Synthes Surgical Power Tool
The Adaptor and Light Adaptor for the DePuy Synthes Small Battery Drive (SBD) and the Small Battery Drive II (SBD II surgical power tool system are power sources for the Synthes Power Tool system. These hand-held power tool systems are used for spine surgery, foot and ankle surgery, hand and wrist surgery, and general traumatology, according to FierceBiotech.com. The adaptors and surgical tool systems are solely used in hospitals or other health care settings.
The recall affects a total of 451 units, according to the FDA. Serial numbers 05.001.024 and 05.001.108 were identified in the recall and the manufacturing dates are between October 6, 2005, and April 5, 2016. Distribution dates are between January 2006 and June 2016. All units were distributed in the United States.
FDA’s Manufacturer and User Facility Device Experience (MAUDE) database revealed hundreds of reports related to problems concerning the DePuy Synthes Small Battery Drive and the Small Battery Drive II devices in 2016 alone including two reports of explosions. “As of today (September 26, 2016), the company has received one report of an adaptor bursting with no injuries occurring. The company has requested that hospitals immediately stop using the recalled adaptors and return them to the company as soon as possible,” DePuy Synthes spokesperson Mindy Tinsley, wrote QMed.
Patients and surgeons, along with bystanders or other staff in an operating room where the DePuy Synthes’ Small Battery Drive and the Small Battery Drive II adaptor and light adaptor tool systems and adaptors are used may be in danger of potential explosions. All operating room staff should be aware of the risks of fire or explosion as a result of anesthetic vapors. Alcoholic skin preparations present a risk of fire or explosion in the presence of high concentrations of oxygen. Mixtures of ether and air in concentrations used for anesthesia are flammable. Static electricity is unlikely to start a fire, but may trigger an explosion if an oxygen-rich gas mixture is present, according to the World Health Organization (WHO).
DePuy Synthes Devices Subject of Prior Recalls
This is not the first recall to affect DePuy. Parker Waichman has long handled orthopedic injury cases involving a variety of orthopedic device makers, including DePuy Synthes.
In 2014, DePuy recalled its jaw-stabilizing Craniomaxillofacial Distraction System, an action the FDA designated as Class 1. The device is designed to lengthen and stabilize the lower jaw in patients with birth or post-traumatic defect, but was found to potentially block airways in infants.
A “Field Safety Notice” was issued by DePuy in March 2015 revealing “the potential occurrence of pain when the native patella is not resurfaced,” reports Mass Device. “When using the LCS Complete RPS Knee System, the patella must be resurfaced. Failure to resurface the patella has been associated with a higher incidence of postoperative patella-femoral pain potentially leading to a secondary procedure,” according to Mass Device.
The increased revision rates alerted Australian monitors. Data from the Australian Orthopaedic Associations National Joint Replacement Registry showed a 3.6 percent higher revision rate at one year compared to 0.3 percent rate with patella resurfacing. Without any resurfacing, the revision numbers increased to 12.9 percent at four years compared to 3.3 percent with patellar resurfacing. As of 2015, DePuy sold 15,571 LCS Complete RPS femoral implants and 17,732 LCS Complete RPS inserts since 2006.
In March 2015, DePuy recalled 1,500 titanium elastic nail inserters used in surgeries to mend long bone fractures. The device was recalled because it was prone to mechanical failure during surgery.
What to do for Users of DePuy Synthes Devices
If you or someone you know sustained injury involving a DePuy Synthes device and are interested in a consultation and further information, please contact Parker Waichman injury lawyers by calling 1-800-YOURLAWYER (1-800-968-7529).