Device is not distributed in the united states, but is similar to device marketed in the usa.Initial reporter is synthes sales representative 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 an unknown date, during inspection, the instruments were difficult to disassemble from one another once they were assembled.There was no patient involvement.No further information provided.This report is for one (1) cent-sleeve f/k-wire ø1.6 f/03.122.054 this is report 3 of 12 for (b)(4).
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