Additional narrative: 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 australia as follows: it was reported that during a scarf osteotomy for hallux valgus procedure on an unknown date, three (3) 2.4 headless compression screws were spinning and required excessive force to be inserted.These 3 screws were not implanted, instead other screws were implanted.This report is for one (1) 2.4mm headless compression screw-short thread 18mm.This report is for 2 of 3 for complaint (b)(4).
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