Additional narrative: 510k: this report is for an unknown drill bit.Part and lot numbers are unknown; udi number is unknown.(b)(6).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on an unknown date, when using the there's a 3.5mm universal drill guide and an unknown drill bits.The drill bit side goes a half way through and then stops.The part was cleaned to make sure it is the right inner sleeve and then all appears to be correct yet for some reason, it is not working.It is unknown where the issue was discovered.Procedure and patient involvement were unknown.This complaint involves two (2) devices.This is 2 of 2 for report (b)(4).
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