The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate is broken from the proximal holes.The holes along the shaft of the plate have deformed threads suggestive of application of cyclic overloading.The pattern on the broken surfaces elicits fatigue fracture.In addition to this, the holes in the distal part of the plate are deformed which suggests cyclic overloading as well.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by repeated overloading of the plate.Patient's bmi is most likely one the contributing factors.Patient details: age- 63 years.Height- 73 inches/ 6'1".Weight- 235 pounds / 106 kg.Bmi- 30.8.If any further information is provided, the complaint report will be updated.
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