The device, used in treatment, was returned for evaluation.The visual inspection of the returned impactor tip confirms the device fractured into two pieces.Both pieces were returned for evaluation.This device exhibits signs of significant use and wear.There is no lot number provided for this device.A medical investigation was conducted and this case reports the impactor broke during use, outside of the patient.Per email communication, all pieces were recovered, and the procedure was completed with a backup device without a surgical delay.Therefore, 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.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
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