The reported event could be confirmed.The medical records were forwarded to a consulting health care professional for review.The comments based on the x-rays and the operative reports are the following: "i do not notice any abnormalities that could have attributed to this event.However, z-deformity or swanneck deformity as described here lead to a high instability of the pip and dip joint in the frontal plane.The dislocation of the flexor tendons to the dorsal aspect of the bone may contribute to high load on the implant." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.However, the real root cause of the reported event could not be determined.If any further information is provided, the complaint report will be updated.
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