Product complaint # (b)(4).This report is for an unk - depth gauges/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 (b)(6) 2021, the patient underwent osteosynthesis of scapula.In the surgery, the surgeon used the depth gauge to determine the length of locking screws used for a plate fixation.The surgery was completed with over 30 minutes delay.After the surgery, x-ray showed that the patient got pneumothorax.After pneumothorax was confirmed, the patient underwent emergency surgery.The surgery was completed successfully.The patient outcome was fine.This complaint involves one (1) device.This report is for (1) unk - depth gauges.This report is 1 of 1 for (b)(4).
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