The sharp kerrison consists of two devices in one to include the reusable handle (device identified in this report) and the tips (single use and reusable version 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.Through testing, symmetry could 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 large or dense bone, the bottom lock with yield.The results of the testing did not break the locking mechanism; however, it did show significant stress in the same location.The type of use is not recommended as it is defined as 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 the stress.The instrument was purchased on (b)(6) 2018 on order # (b)(6).Initial inspection of the instrument confirmed that the bottom locking mechanism was broken.The rapid clean kerrison is manufactured with the upgraded design and therefore has the improved locking mechanism.The material and hardness are within conformance per the product specifications.Per the design of the instrument, if enough force is applied to the instrument, breakage can still occur.This is the second complaint that has been received with (b)(4) sold of the improved design.This is a significant improvement in complaint rate.The sales representative has scheduled a re-training for using the device.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow-up report will be submitted.
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