Occupation: synthes employee.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 that the depth gauge tip is broken off.Also, the benters are dented and plate slips out when bending.There are no patient consequence.Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity # 1).This report is for 1 of 1 for (b)(4).
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