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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, an open reduction internal fixation (orif) surgery was performed with multiloc humeral nail (mhn) system for proximal humeral diaphyseal fracture.During insertion of a titanium locking screw for distal side stopping, the surgeon used a drill bit with 4.2mm in diameter, instead of a 3.2mm in diameter.So, the locking screw was inserted into the affected hole which had been created by the drill bit with 4.2mm.However, the surgeon thought that it could not fix the unknown plate with enough force since the hole had been created with the 4.2mm drill bit instead of the 3.2mm.Thus, the locking screw was removed, and the screw was inserted into another hole.The surgery was completed with a 30-minutes delay.The patient is confined in the hospital.There was no adverse consequence reported to the patient.Concomitant devices: (part: unknown, lot: unknown, quantity: 1), locking screw (part: 04.005.414s, lot: 3l10461, quantity: 1).This report is for a 4.2mm three-fluted radiolucent drill bit.This is report 1 of 1 for (b)(4).
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