A facility reported that the torque screw of the mayfield modified skull clamp (a1059) came unscrewed.It is probable that this occurred during a surgery, and a doro device was used to complete the surgery.Additional information received indicates that there was no incident, and the surgeon managed to screw/ tighten the torque screw at the end.The device was kept for another scheduled surgery on the same day.There was no consequence for the patient.
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The mayfield skull clamp (a1059) 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 was unable to duplicate the reported issue, however, unrelated to the issue, the unit had a sticking swivel lock assembly and a residue buildup.Also, some worn off internal parts needed to be replaced along with the damaged index knob to adjust the swivel lock assembly.As a result, the internal parts to adjust the unit according to the manufacturer were replaced and the swivel lock assembly was cleaned.General maintenance and cleaning were performed, and after completing the reassembly the skull clamp was subjected to a successful function test.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint as no issues were noted with the torque screw.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further investigation is 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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