The complainant reported that an axle all in one inserter broke during insertion of an implant.A second inserter was available, and the procedure was completed.There were no known patient complications.Visual assessment of the instrument identified that a subassembly part was sheared off which would prevent the inserter from functioning as intended.The fracture appeared to start on the inside corner of the tip where there is a sharp corner and potential stress riser.A dhr review was performed, and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.
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