DePuy Sythes Surgical Tool Batteries May Explode, FDA Warns
Federal regulators are warning that some DePuy Sythes surgical tool battery drives may explode suddenly, resulting in a class I medical device recall due to the risk of serious injury or death associated with the defect.
The DePuy Synthes recall was announced by the FDA on September 28, indicating that the small battery drive adaptor can produce extreme internal pressure, which could cause them to explode during surgical procedures.
The adaptors power the DePuy Synthes Small Battery Drive and Small Battery Drive II surgical power tool systems, which use attachments for drilling and cutting bones during orthopedic surgery. The FDA warns that if the devices explode, it could cause injuries or even death to surgeons and other healthcare providers, patients undergoing surgery, or bystanders and other staff in the operating room.
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DePuy Synthes first announced the problem in a notice to affected customers in January, and initiated a former recall on June 24. This week the FDA declared that recall to be Class I, meaning that the agency believes use of the adaptors could result in serious injury or death.
The recall affects Adaptors and Light Adaptors for the DePuy Synthes Small Battery Drive (SBD) and Small Battery Drive II (SBD II) surgical power tool systems, with serial numbers 05.001.024 and 05.001.108. They were manufactured from October 6, 2005 through April 5, 2016, and distributed between January 2006 and June 2016. About 451 units in the U.S. are affected.
Depuy has asked its customers to identify and quarantine the devices, and to complete and return verification sections of the recall notices it has sent out. Customers can contact DePuy Synthes at 1-800-327-6887.
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