The device, used in treatment was returned for evaluation.Visual inspection of the returned device is broken and confirms that the device has signs of wear and tear from use.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 complaint history for the listed part revealed no prior complaints.According to clinical/medical investigation, the trial liner broke during the procedure; however, there was no patient injury/harm or surgical delay reported.It was communicated that the lot number and operative report were not available and responses to remaining requests were not provided.The product evaluation remains pending at the time of this assessment.Patient impact beyond the reported event is not anticipated as no injury or surgical delay was reported.Therefore, no further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 and the instructions for use 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.
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