The deviation found on the skull clamp sent in (clamping force of the torque screw slightly above the specification) and the outdated pin insertion cannot have contributed to the event described by the customer (slippage).Therefore, no causal link can be established between the device and the reported incident.The maintenance interval of one year specified in the product's instructions for use was exceeded by the customer by 2 years and 8 months.The findings on the device described in this report could not have gone undetected during such a routine inspection.As none of the deviations found in this inspection are assumed to have contributed to 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." information relevant to this report (skull pins used, date of incident, clamping force applied, etc.) was not provided despite repeated queries by the manufacturer to the reporting parties.If new information or findings are received, these will be subsequently submitted in a follow-up report.
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