The device, intended for use in treatment, was return for evaluation.Our investigation included a visual inspection of the device and confirmed the nuts are broken on the rulers which confirmed the stated failure mode.This failure mode has been previously identified.Since the manufacturing of the complaint device, a design change was implemented to eliminate/reduce the occurrence of this failure.Only the outside of the ruler was returned.The lot number is unreadable on the device.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.
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