This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: screw disengaged and fell in the patient.Probable root cause: design - inadequate driver/handle interface design.- inadequate driver/knob interface design.- inadequate screw/driver interface design.- inadequate raw material for driver tip, shaft, knob, handle or screw.- inadequate surface finish for driver/knob interface.- inadequate screw thread design for bone engagement or suture interface.- inadequate design relationship between tap and screw (causing previous screw.Insertion to be difficult, twisting the driver).- inadequate design relationship between awl size and screw (causing previous screw insertion to be difficult, twisting the driver).- inadequate design relationship between eyelet size and screw (causing previous screw insertion to be difficult, twisting the driver).- inadequate design relationship between screw and versitomic reamer.Process; - tap or screw not manufactured to specification.- driver not manufactured to specification.- knob or driver handle not manufactured to specification.- incorrect material used during manufacturing.- incorrect assembly performed for screw/driver or knob/driver.- screw assembled upside down.Application; - user applies excessive force to torque screw.- user does not drill/tap pilot hole.- user does not go to laser line (incomplete tapping/drilling/awling).- inadequate assessment of bone quality.- user re-loads a new screw upside down.- use of incorrect drill size for associated screw.- eyelet causes interference with screw during insertion.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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