The device was returned on 10/25/2018 confirming that it was the old style sold in 2016.The sharp kerrison consists of two devices in one to include the reusable handle (device identified in report) and tips (single use and reusable versions available) assembled to complete the usable device.The detachable tips were specifically designed as removable to support use and removal once dull which is common for devices with a cutting feature.Unfortunately the tips were not returned alone with the handles to assess this condition.Through testing, symmetry was able to identify that when additional forces are applied to the locking mechanism of the handle by excessively squeezing and twisting the handle during the use of a dull blade or while cutting a large or dense bone, the bottom lock will yield.The results of the testing did not break the mechanism, however, it did show stress in the same location.This type of use is not recommended as it is defined as a warning in the ifu.Based on the results of the testing, symmetry chose to further improve the safety of the product by increasing the thickness of the bottom locking mechanism that experiences all the stress.This can be seen as the final report.If additional information is obtained that alleges the need for corrective actions or indicates a risk to patient safety, a follow-up report will be submitted.This report is being submitted retrospectively per fda request.
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