Complaint sample was evaluated and the reported event was confirmed.Product identity is confirmed.The screw was returned without original packaging for evaluation.On visual inspection, the tip of the screw shows minimal damage.However, the drive on the screw head shows significant damage and stripping, indicating an insertion attempt.Functional testing for the screw's retention was attempted by mating it to 15-1196 1.5mm ht x-lock blade with a 01-7390 green handle screwdriver assembly; the screw would not retain to the blade and repeatedly fell off.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to damage during the insertion attempt by way of an off-axis insertion attempt, over torqueing, using the incorrect blade, or the patient having high bone density.The unknown blade was not returned, therefore functional testing and inspections could not be made regarding this part and how it relates to the complaint and potential root causes.The instruction for use (ifu) for this product has the following information regarding bone screws: 1.The screwdriver, which has been designed, for a particular system of screws must always be used to be sure that proper screwdriver/screw head connection is achieved.2.Incorrect alignment or fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver.3.Excessive torque can cause the screw to fracture.4.Self drilling screws may fracture, bend or break if used in a bicortical application.There are no indications of manufacturing defects.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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