A visual assessment of the returned complaint screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip was sheared off as reported, and the remaining portion was twisted in a manner that suggests it was being rotated counterclockwise when the instrument malfunction occurred.A functionality assessment was not performed due to the damaged condition of the instrument, which was removed from distributable inventory.The torque driver handle returned was not within specification and was removed from distributable inventory, which was determined to not be a factor for the cross connector removal because it does not limit applied torque in a counterclockwise rotation.A dhr review was performed for the screwdriver complaint lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/11/2016.The alternate surgical system contains the appropriate instrument for cross connector implantation and removal.It is unknown why the physician elected to use a screwdriver from a different surgical system for the cross connector removal.The distal tips of the two screwdrivers are very similar, but not interchangeable for function in different surgical systems.The transition from the screwdriver tip to the main shaft is different, the overall instrument length is different, and the angle of the distal end of the driver is different.The root cause of this event is the use of the incorrect instrument.There have been four other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
|