Initially kalitec was made aware of a potential issue with the inserter/draw rod.No report of patient injury was made.Based on the available information and evaluation of the returned instruments it was determined that no report was required.However after the distributor which returned the instrument provided additional information on (b)(6) 2024 the event was reevaluated and a report was determined to be required.The report will be made at a point greater than 30 days from when kalitec was made aware of the instrument malfunction but less than 30 days from when they were made aware of the patient injury.The time from becoming aware of the injury and the report was used to complete the expanded investigation which included the new information provided by the distributor.
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