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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.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 depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery with the df and the plt for the distal femoral fracture.The surgeon attempted to insert a 25 mm cannulated locking screw into the screw hole of the plt; however, there was no 25 mm cannulated locking screw in the set.Therefore, another 24 mm locking screw was used for surgery.The surgery was completed successfully without any surgical delay.In the preoperative meeting between the sales rep and the surgeon, the sales rep informed that the cannulated screw size standard was 25 mm to 90 mm.However, the sales rep did not know that 25 mm and 90 mm were not included in the set from this october.No further information is available.This report is for one (1) 5.0mm ti cannulated locking screw 25mm this is report 1 of 1 for complaint (b)(4).
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