It was reported that, during a meniscal root repair procedure, the cannulated drill pac was found with only 1 unit of drill and 1 unit of sheath.As it was a double tunnel meniscus root, the procedure was completed without delay as the ot staff managed to find another sheath (hospital unit).There was no delay.No patient injury or other complications were reported.
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Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.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 complaint history did not reveal similar events for the listed device.A review of the packaging sequence revealed that the sheath should contain three units of drill.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Manufacturing process errors could be probable causes of the reported event.With no other complaints for the batch, we consider this an isolated event.However, we will continue to monitor this failure mode in the future.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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