Please note correction to h6 (device code).The reported event could be confirmed since the device was returned and matches the alleged failure.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Heavy explantation marks were observed on the inner surface of the hole and the fracture surface as well, mostly in the distal segment.We can see the load-bearing points on the proximal part of the broken nail which indicates overloading.We can also see the presence of breakage in an oblique manner which indicates towards application of high torsional load.Bearing points of the lag screw at the medial edge of the proximal hole showed significant deformation, indicating the high compressive load.Signs of overloading were also evident at the distal oblong hole.The breakage pattern resembles a fatigue breakage, having equal portions of fatigue zone and instantaneous zone indicating that the breakage was initiated in a fatigued manner but quickly broke instantaneously under high compressive loading.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.Based on the investigation, the root cause was attributed to patient related factors as breakage was due to high compressive load and with available overloading signs on nail.If any additional information is provided, the investigation will be reassessed.
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