During shoulder sub-acromial decompression procedure when the surgeon used the burr, there were metal shavings noted.The surgeon experienced seizing of the device and shedding was observed towards the end of the procedure.The position of the burr was flush, relative to the tissue.The bone was noted to be fairly hard.There were no anatomy or procedure exceptions, and it did not appear that more force was required on the device than typical.The debris was suctioned out, but it is unsure if the surgeon was able to remove all of the debris.There is no product to return for investigation purposes as the device used in the procedure was discarded by the facility.
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Evaluation of the device was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.
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