It was reported that, during a tsa surgery, doctor was using a 2.8mm glenoid drill shaft with a glenoid reamer extra small to ream the surface of the glenoid.The reamer was catching on the retractors that they had in place which broke the tip of the drill shaft that captures the reamer.Two small pieces of metal were removed from the shoulder which the surgeon confirmed were the only broken pieces of metal in the shoulder.The procedure was performed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
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H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the tip of the drill is fractured.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.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 specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.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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