The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: investigation shows that the rocker arm has up and down movement and grinds in the unlocked position.The starburst teeth show signs of wear, but still pass all specific functional testing.The disk ratchet and retainer were replaced due to wear.The 80lb torque knob was replaced due to the retaining ring coming off.All worn components was replaced with new part and general cleaning and maintenance performed.Root cause: complaint confirmed via inspection of the unit.Probable root cause is normal wear and tear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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This is 2 of 3 reports linked to mfg report numbers: 3004608878-2022-00261, 3004608878-2022-00263.A facility reported that the rocker arm of the mayfield composite series skull clamp (a3059) moves while in locked position.In addition, starburst teeth are worn down.No information on patient involvement, injury, or surgical delay was received.
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