Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, it was confirmed that foreign objects were adhered to the screwdriver, the drill bit, and the reamer when the sterilization agent inspected the devices.Foreign objects were also found in the hollow interior of the devices in question.Although the devices were for the surgery on (b)(6) 2023, the surgery was cancelled.This report is for a screwdriver.This is report 1 of 3 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer.Review/investigation.E3: initial reporter is a depuysynthes sales representative.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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