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 (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for femoral trochanteric fracture.During the surgery, the surgeon couldn¿t connect the reamer head to the shaft firmly.The reamer head was easy to come off from the shaft.The surgeon applied the force to connect them and they were connected successfully.The surgery was completed successfully within thirty (30) minutes delay.Patient outcome is reported as stable.No further information is available.This report is for one (1) 5.0mm flexible shaft this is report 1 of 1 for complaint (b)(4).
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