The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - complaint confirmed via inspection of the item.The unit received with the lock having rotational and lateral movement, requiring replacement of worn internal components.Unit received with the lock having rotational and lateral movement and a residue buildup was present.New components were added to replace worn internal parts.General maintenance and cleaning required at this time.Replacement of worn internal parts.Root cause - complaint confirmed.The returned skull clamp lock had rotational and lateral movement.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2008), thus required preventive maintenance and replacement of worn parts as a result of routine wear and tear.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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This report is 4 of 4 linked to mfg report numbers: 3004608878-2021-00694, 3004608878-2021-00695, 3004608878-2021-00696.A facility reported that the mayfield modified skull clamp (a1059) would not release with the spring gross loaded knob, and the knob binds when trying to pull out.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.After the device was returned by the customer, evaluation showed that it had movement.
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