It was reported that, when opening the box of two (2) 3mmx1000mm ball tp gde rd during a trauma surgery, it was found that the rod was breaking through the sterilization bag.It is unknown how the procedure was completed and if there was any surgical delay.Patient outcome is unknown.
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device¿s packaging was found to be punctured by the guide rod, rendering the device inoperative.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According to the packaging sequence, the guide rod should be inside the pouch and sealed as close to the end cap.A contribution of the device to the reported event could be corroborated as the devices packaging was found to be compromised.Factors that could contribute to the reported event include damage during shipping and/or damage during storage.Based on this investigation, the need for corrective action is not indicated.This issue was evaluated through our internal quality process, and the packaging will be optimized to prevent this issue.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
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