Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-ray¿s were provided and no material was returned for investigation.Product was not returned therefore no further investigation possible.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 (information or/and material), 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent the surgery with the screws and the screwdriver.During the surgery, the surgeon couldn¿t hold the screw with the screwdriver, and he couldn¿t insert the screw.Eventually, the surgeon couldn't insert the screw completely.The surgery was completed with less than 30 minutes delay.After the surgery, when the surgeon tried to hold other screws with the same screwdriver, he could hold them without any problem.This report is for one (1) ti matrixmidface screw self-tapping 8mm.This is report 3 of 4 for (b)(4).
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