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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It was reported that during a tibial nail surgery on (b)(6),2018, two (2) medullary reamer heads were left in the patient.The surgeon did not use a ball tip reamer rod during the reaming part of the procedure.Procedure was successfully completed.Patient outcome is unknown.This report is for a 9.0mm medullary reamer head.This is report 1 of 2 for (b)(4).
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