The device, used in treatment, was returned for evaluation.A visual inspection confirms the driver shaft tip is broken off.The broken piece was not returned with the device.The instrument was manufactured in 2018.The device exhibits signs of significant use and wear.A medical investigation was conducted and this case reports the tip of the driver shaft broke during the procedure.Per email communication, there was no patient injury or delay, and the procedure was completed with a backup device.Since no patient harm is alleged, no further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.
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