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 an unknown date, the multiloc proximal humeral nail for right was delivered to the hospital.The hospital originally wanted the multiloc proximal humeral nail for left, but the sales rep made typo.When the implant was delivered, the hospital wasn't aware of the mistake.On (b)(6) 2019, the patient underwent open reduction internal fixation surgery for left proximal humerus fracture with the humeral nail for right.After the patient was under anesthesia, the surgeon was aware of the mistake, but the surgeon implanted the humeral nail for right without any change, and the surgery was completed successfully.The surgical delay is unknown.No further information is available.Concomitant devices reported: unknown locking screws (part#unknown, lot#unknown, quantity unknown).This is 1 of 1 for report (b)(4).
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