Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a drill bit clashed with the nail during the locking step of an expert nail procedure on (b)(6) 2015.The surgeon reportedly had to manually insert the distal nail blocks and use strength to lock the nail holes.A forty-five (45) minute surgical delay was noted.This report is for one (1) unknown drill bit.(b)(4).
Manufacturer Narrative
Patient initials are (b)(6).This report is for one (1) unknown drill bit.Device is an instrument and is not implanted or explanted.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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.