The complainant requested to return a serious of broken instruments for replacement.The complainant was unable to provide details regarding the incidents.There were no known patient complications associated with the malfunctions.The following mdrs are related to the receipt of this complaint.3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.The rotating rod inserter had worn laser markings and surface scratches, indicating that the instrument was used repeatedly.One of the prongs at the distal end of the instrument was bent outwards and the other was broken and not present.A dhr review was performed and the instrument met all require specifications prior to being made available for distribution on 7/15/2016.The prongs at the distal tip of a rotating rod inserter may become damaged if the instrument were moved laterally while the attached rod was engaged with a screw extension and pedicle screw construct.Lateral movement while engaged with a screw extension and pedicle screw concentrates applied force to the interface between the rotating rod inserter and rod, which may result in the prongs of the inserter becoming misshaped and broken.The rotating rod inserter was inspected and determined to not be in functional condition and was removed from distributable inventory.
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The complainant requested to return a serious of broken instruments for replacement.The complainant was unable to provide details regarding the incidents.There were no known patient complications associated with the malfunctions.The following mdrs are related to the receipt of this complaint.3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.
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