FDA warns Synthes facility over complaint handling procedures

Synthes has not had the best couple of weeks. The company, which is facing legal action from families whose loved ones died after receiving a Synthes bone cement product, is facing other problems--this time from the FDA over problems at its West Chester, PA, facility. That facility makes Click'X 3-D polyaxial heads, Click'X 3-D pedicle screws and N-Hance rods.

According to the FDA, which sent the company a warning letter dated Feb. 16 and just posted to its website, Synthes has failed to promptly and properly investigate complaints related to products made at the facility. Although the company, which is awaiting final regulatory blessing to be acquired by Johnson & Johnson ($JNJ), is required to look into complaints "in a timely manner," it fails to define exactly what that means.

Company employees are required to "immediately communicate" such problems to a complaint handling unit. But a review of Click'X 3-D head and N-Fix II/N-Hance rod complaints showed that they didn't always do so, the FDA says. In addition, that complaint handling unit must make a good faith effort to obtain more information about an issue brought to its attention unless the complainant hasn't supplied such details. Oftentimes, there is no time period specified to obtain this information, and the agency says there are examples in which complaints "were found to either not have a documented follow-up or untimely follow-up attempts for missing information," according to the letter.

Synthes is looking to resolve these issues. "We will co-operate and work diligently with the FDA until these deficiencies are fully resolved," company spokesperson Gilgian Eisner said in email to Reuters.

The posting of the letter comes on the heels of news the company is being sued in California. The families of two women who died after receiving a Synthes bone cement product are suing the company and four former executives in the California Superior Court, alleging wrongful death and elder abuse.

- read the FDA's letter
- get more from Reuters

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