H3, h6: the device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is cracked and has signs of wear and tear from use.According to clinical/medical investigation, the trial poly was broken before it was even used.The surgeon used the actual 8mm to trial and found it to be good.The procedure was completed trailed the actual 8mm poly.No report of delay in case.No pieces fell into/or reached the patient.No harm or impact to the patient reported.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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.
|