Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the image provided.The image was reviewed, and the complaint condition cannot be confirmed.There is no evidence of any defects with the tfna fenestrated screw.A valid lot number was not provided.If a valid lot number becomes known, a manufacturing record evaluation will be performed.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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