As it was discovered during the investigation that the release button of the skull clamp was broken, the customer was contacted to ask whether he had noticed this deviation during use or before complaining about the product, as he did not mention the defect in the description of the complaint.The customer stated that he had not noticed any abnormalities with regard to the safety or functionality of the product since the last manufacturer service.As it is very unlikely that the breakage of the skull clamp's release knob went undetected by the customer, it is assumed that the breakage was caused by an external impact (lateral force) during transportation of the skull clamp to the manufacturer's service unit.It is therefore not assumed that the deviation existed at the time of the incident (slippage) or could have contributed to the incident.We suspect that maybe the pinning technique has not been 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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