The mayfield modified skull clamp (a1114) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The swivel lock opens and closes according to the manufacturer's specifications; there is no movement.The starburst teeth and inner threads have no defect, and the ratchet extension can be inserted fluidly into the skull clamp base and can be unlocked properly.The swivel base assembly rotates smoothly throughout the 360° rotation, the index knob has a positive rollover, and the plunger assembly does not contain any free movement when the ratchet extension is removed.No maintenance is required at this time, as the unit met all manufacturer specifications.The unit has been subjected to a successful functional check, and the device has been scrapped.Root cause - the complaint is not confirmed.The returned unit is in good working order and meets all manufacturer¿s specifications.Probable root cause is improper use or customer error.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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