The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - investigation of the returned skull clamp showed a loose swivel lock and a residue buildup was present.Some worn off internal parts needed replacement along with the swivel base, which could have a worn off inner thread.The skull clamp's base was also worn also had worn off starburst teeth, and the base casting needed replacement.As a result, new components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Service and repair found no deficiencies with the torque screw.However, the unit was showing signs of wear.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.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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