The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - evaluation was unable to conclusively verify customer information as valid as service team was unable to duplicate slippage.With respect to the returned unit, it has passed all specific functional testing requirements, except for the lock having rotational movement when the unit is not under pressure.This would not have caused a slippage.When the unit is properly positioned and put under pressure, it would not have slipped.Unit received without plunger cap, plunger stud and spring, thus all worn components were replaced with new parts.General maintenance and cleaning was also performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs team could not duplicate slippage.Probable root cause is improper placement of the skull clamp.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
|
This is 1 of 2 reports linked to mfg report number 3004608878-2021-00707.A facility reported that when patient was put in pins with mayfield modified skull clamp (a1059) and spine table adaptor base unit, the patient moved during the procedure as the patient¿s positioning changed.Since the skull clamp is a part of the system, the customer sent in both units for further inspection due to the incident.No patient injury or surgical delay has been reported.
|