Method: device not returned.Additional manufacturer narrative: although these devices are reusable, they do not have an indefinite shelf life.According to the directions in the instructions for use (ifu) supplied with the accessories, sizers and sizer handles must be disassembled before re-sterilization.The accessories should be examined for signs of wear, such as dullness, cracking, or crazing, and do not use if deterioration is observed.In this case, the maintenance and usage information has been requested but not received.The device has not been returned for evaluation and follow up attempts to obtain the device and further information are in progress.Therefore, we are unable to confirm the clinical report or investigate further into the root cause for fracture of this device.Should new information or the complaint device is received at a later date, a supplemental mdr will be submitted.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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