This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: lot ktcb: received 11/nov/2021, lot jjan: received 11/nov/2021; manufactured 25/jun/2019, unknown lot - will not be returned.The returned inserters were visually and functionally inspected.The distal tips appeared to have a slight angulation with respect to the inner shaft.It is unknown if this occurred due to off axis loading while attempting to disengage the inserter from the screw head or not.The inserters were able to successfully engage and disengage with a model yukon screw using normal force.Therefore, the products performed as expected.Device history records were reviewed for lot jjan and no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog and three (3) similar complaints were identified.The reported issue could not be replicated during functional inspections.However, bench testing cannot account for abnormal forces or patient anatomy experienced during procedures.According to the surgical technique, to fully seat the inserter into the screw-head, the inserter has to be completely aligned with the screw.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface, reduce torque overloading, and reduce failures as reported.If forces are not evenly distributed throughout the screw and inserter interface, jamming of the components can occur due to offloading.However, as the reported issue could not be replicated using normal force, a root cause cannot be conclusively determined.A supplemental vmsr will be submitted upon completion of the remaining investigation.
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