The device, used in treatment, was returned for evaluation.A visual inspection confirms the flexible shaft is bent in the middle of the device.Also the visual confirms the end of the device broke off.The broken piece was not returned for evaluation.The piece that broke off holds the lot number.The lot number is not available for this device.The device exhibits signs of extreme wear/usage.A medical investigation was conducted and this case reports the flexible shaft w/cir connector broke off while reaming canal of femur.Per complaint details, there was no patient injury, and the procedure was completed without delay, using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.We consider this investigation closed.
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