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Stryker issues field safety notice for Triathlon MIS Modular Distal Capture device
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Stryker Orthopaedics recently issued a field safety corrective action for its Triathlon MIS Modular Distal Capture device, as the company has received customer complaints of the device disassociating during use.
According to the field safety notice issued by Stryker, a dissociated device also may result in local inflammatory responses, inflammation, an inflammatory response, revision surgery to retrieve a loose spring, and complications linked with both extended surgery times of less than or equal to 15 minutes and those greater than 30 minutes.
To mitigate these risks, the notice highlighted the instructions for use of the device call for the testing of instruments with articulating surfaces for movement and that Stryker Instructions for Cleaning, Sterilization, Inspection and Maintenance of Orthopaedic Medical Devices note that “instruments with moving parts should be operated to check correct operation.”
According to the field safety notice, “Performing these inspections as instructed after cleaning many cause the device to disassociate prior to reaching the operating room. This may mitigate all of the hazardous situations.”
Stryker Orthopaedics noted that those who have these devices should inventory and quarantine the devices for the return to Stryker. In addition, companies should inform Stryker if any of the subject devices have been distributed to other organizations. Any company with the device should report adverse events related to the Triathlon MIS Modular Distal Capture device to Stryker and should comply with any local regulations concerning the notification of these events to national or local authorities.
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