Please note the correction to d9/h3 as the device was returned for evaluation.Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed, since the device is broken as complained.The device inspection revealed the following: the visual inspection has shown that the base lever, where the lever arm is fixated, is broken apart at the crossover from the smaller to the bigger diameter of the cylinder head screw holes.The damage pattern shows that the fracture surface was torn apart at very high forces.The inspection of the recess at the cylinder head screws shows that there are deformations at the top of the recess visible, this is an indication for a manipulation at the screw that occurred post-manufacturing.Also at the lever arm are stress marks in the area of the base lever visible, these marks are also an indication that the arm was moved post-manufacturing.In general is the device is in a used condition, there are wear marks at the bent sleeves visible.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.Nevertheless it can be mentioned that the design of the base lever has been improved in the meantime as part of our continuous improvements to avoid such an occurrence in the future.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mechanical overload during the bending of a plate.A manipulation at the screws in this area may also have played a certain role as an over-tightening or insufficient tightening the screws could have resulted in a stress riser in the area of the breakage.If more information is provided, the case will be reassessed.
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