Manufacturing and inspection records were reviewed, and no anomalies were found.The returned product was inspected under magnification.Under magnification it was noted the area containing the batch number on the mini acutrak 2 drill, long (part number at2m-l1813) was badly scratched and difficult to read with the only numbers legible as 378 (matching the indicated batch number on the autoclave pouch as 526378).Inspection under magnification revealed the returned drill showed signs of wear both on the shaft and at the drill tip.There were scratches around the shaft of the drill, obscuring and eliminating areas of the batch number laser marking as indicated above.Additionally, at the tip of the drill, the cutting flutes were dented and deformed.The edges around the cannula at the drill tip also showed signs of wear and denting.In addition, one of the cutting flutes showed a small area of denting/dulling.Otherwise, no significant signs of damage were observed.It is possible that the damage observed dulled the drill, even when the denting and wear was slight.However, no definitive conclusion can be made.
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