(b)(4).Report source - canada.The setting instrument has been returned for an investigation.A surface alteration is detected as the entire metal part of the instrument seems matt.The blue handle of the instrument shows a small crack.The tip of the instrument has fractured off and the ring is missing.Additionally, there is no lot number but the laser-marking 11-14 visible on the instrument.Review of the device history records could not be done as the lot number was not seen on the device.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.The root cause of the reported event was determined to be related to a previously identified design issue.The device has since undergone a design enhancement through the capa process to address this issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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