Additional information provided.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.Photos of the product are attached to the parent file and have been reviewed by the manufacturing site.The photos confirm that the tip of the probe needle is broken at the port.One opened probe was received and visually inspected and was found non-conforming with a broken tip of the probe needle and a slightly bent needle.Functional testing could not be performed due to the tip being broken off.The probe was disassembled and the components inspected.Excessive wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter is bent.Gouge marks were observed at the bend area, cutting edge, and several other locations along the inner cutter.The complaint evaluation confirmed that the probe had a broken tip at the port.Functional testing could not be performed to determine whether or not the probe produced abnormal noise as was reported.The exact root cause for the broken tip cannot be determined from this evaluation.The most likely contributing factor to the broken tip at the port is excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe had experienced a use much greater than this typical timeframe.An internal investigation has been initiated to further evaluate the cause of probe tip breakage at the port.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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