It was reported that, during maintenance, it was found that inner parts of a ri robotic drill attachments broke.No case involved; therefore, there was no patient involvement.
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The ri robotic drill attachment, rob10015, (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.One of the bearings of the drill attachment came apart.A functional evaluation was performed.The reported problem was confirmed.Further disassembly of the device during functional evaluation revealed the top most bearing experienced wear and came apart.The most likely cause of this event is regular wear and tear of the device, leading to the bearing breaking down.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.
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