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The mayfield modified 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 - evaluation of the returned unit is unable to duplicate slippage; the lock has rotational and lateral movement, and a residue buildup is present.The lock does have slight lateral and rotational movement, but when the clamp is properly positioned and put under pressure it will not move.The unit has no service history since being sold in 2020; new components will be added to replace worn internal parts, and general cleaning and maintenance will be performed.Further, the unit was sent to quality engineering for further investigation as a precaution, and the initial findings were confirmed by quality engineering (there was slight movement in the lock).No additional device deficiencies were observed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.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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A facility reported that during posterior cervical fusion procedure, the surgeon had the pressure set on the mayfield modified skull clamp (a1059).Patient was flipped to prone and all the pressure released, causing the patient's head to fall out of the clamp.However, the surgeon was able to catch the patient's head since it was during positioning for the surgery, as he was standing there.Additional information subsequently received from reporting facility as follows: 1.Was there patient injury? if yes, please provide details surrounding the injury.Patient received a scratch from the pin grazing their head as it was falling from the mayfield.No more significant injury because it happened during positioning so surgeon was able to recognize what was happening and caught the head as it released from the traction.2.Was there a delay in the procedure due to the product problem? there was a delay as the patient had to be returned to the patient cart, from prone position back to supine.The pins were replaced, our second mayfield holder was used, and the patient was once again turned prone and the head was secured.B) no adverse effects from delay.3.How long was the delay in minutes? it would have been less than 30 minutes.4.How was the procedure completed? procedure was completed when patient was re-positioned in our second mayfield.5.Current status of the patient.Patient's surgery was completed and no adverse effects that i am aware of.
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