Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during an unknown procedure, both polyaxial screwdriver holders were stripped.One of the screwdrivers cold welded a screw to it and could not be removed.This report is for one (1) unknown screw this is report 2 of 2 for (b)(4).
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Additional narrative: this report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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