This report is for an unknown drill bits: trauma /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.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.(b)(4).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) 2020, during an unknown procedure the surgeon was unable to locate the screwdriver.The surgeon intended to use the plate and screws from a 2.0 compact foot system.Due to not being able to locate the screwdriver, the surgeon had to drill with a 2.4 drill.There was a twenty (20) minute surgical delay.There was no consequence to the patient.This report involves one (1) drill bits: trauma.This is report 1 of 1 for (b)(4).
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