It was reported that during a surgery, a my 3d personalized reconstruction drill bit had dulled during use, and it was reported that the bone looked discolored.The procedure was able to be completed successfully.Additional information regarding this event is not known at this time.This event will be reported to the fda as a malfunction.
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During a my3d pelvic reconstruction case ((b)(4)) on (b)(6) 2023, the surgeon had difficulty drilling holes with the non-sterile 4.3mm x 200mm calibrated drill bits.Three drill bits were used and were reported to be dull.Additionally, after the drilling operation, black particles were reported to be seen around the drilled area.The drilling operation was able to be completed successfully using alternative drill bits.The issue captured in this complaint contributed to a surgical delay of 15 minutes to the case.Three my3d pelvic reconstruction drill bits were reported to be dull.It was reported that the patient had sclerotic bone, and the surgeon had to use three drill bits.The root cause of this issue could not be determined conclusively.It was noticed that debris was present after drilling, which could have been caused by drilling into existing hardware,drilling into sclerotic bone, etc.However, the cause could not be determined conclusively.
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