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 expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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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Device report from synthes reports an event in japan as follows: (b)(4) are related to each other.This pc captures a syn product.It was reported that on (b)(6) 2024, the patient underwent an orif surgery for a femoral shaft fracture.When the drill bit was used, it broke off in such a way that it was twisted off at the root.Incision was done by an awl and medullary reaming.The radiolucent-drive got stuck and stopped working during use.A distal locking screw was inserted manually.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for one (1) drill bit ø14 cann flex f/quick coup f/d this is report 1 of 1 for complaint (b)(4).
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