The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the device fractured into two pieces.Both pieces were returned for evaluation.The device shows extreme signs of wear/usage.The device was manufactured in 2004.A medical investigation was conducted and this case reports the trial insert broke in half while inside the patient.Per complaint details, the procedure was completed using a backup device, with further complications.A photo of the device confirms the device broke in two.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.
|