The investigation of the product which, according to the customer, was involved in the reported incident had not yet been completed at the time of the initial reporting.This report presents the results of the product investigation.After careful inspection of the rejected product, it was found that the device shows no deviations or other abnormalities with regard to functionality and/or safety.As the device did not show any deviation that could cause the reported incident we suspect, that maybe the pinning technique has been not optimal as described in the instruction manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline.".
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