This report is for an unknown screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for proximal humerus fracture with the aiming arm in question.Before the surgery, the surgeon checked devices, and he found that there was no problem.During the surgery, the surgeon inserted a nail (multiloc short f9.5mm) connected with the aiming arm.The surgeon confirmed that the nail connected to the aiming arm firmly.The surgeon could drill and insert screws into the proximal 3 holes.The surgeon attached a centering sleeve, and he tried to insert the distal screws.The surgeon drilled distal one hole, and he tried to insert a screw, but the screw wasn¿t inserted properly.When the surgeon tried to drill distal second hole, a drill bit moved upward.The surgeon stopped using the aiming arm, and he inserted screws with his hands.The surgery was delayed by thirty (30) minutes.The surgeon commented that the defect cause might be that he applied force to the aiming arm to reduce the fracture part.Procedure was completed successfully.Patient outcome was reported as stable.No further information is available.Concomitant devices reported: nail (part#unknown, lot#unknown, quantity 1), drill (part#unknown, lot#unknown, quantity 1), centering sleeve (part#unknown, lot#unknown, quantity 1).This report is for one (1) unknown screw.This is report 3 of 3 for complaint (b)(4).
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