It was reported that during an arthroscopy, when using 2.6mm drill bit spade for the 2.3mm bioraptor suture anchor to prepare hole for osteoraptor 2.3 anchor - drill had been used for hole preparation of 2 anchors in patient already.While drilling 3rd hole with use of drill guide, the blade of the drill snapped off and lodged in patient's cortical bone.The body of the drill was removed still attached to the jacobs chuck and handpiece.The blade/head of the drill lodged in the bone was removed with an alligator grasper.It was believed that the break was clean as no other parts of the drill could be seen.The procedure was completed with non-significant surgical delay using a back-up device.No further complications were reported.
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Internal complaint reference (b)(4) h10 h3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The drilling head fractured just below the proximal end of the cutting surfaces.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that a procedural variance could not be ruled out as a likely contributory factor.The ifu does warn, ¿excessive force applied to the instrument can result in the instrument¿s failure." the root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device, off-axis insertion, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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