Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent the open reduction internal fixation with vatcp for the distal radius fracture.There was only one cortical screw in question mixed in with the row of va locking screws in the implant set case where the va locking screw implants were to be placed.Instead, the row of cortical screws contained a va locking screw.When the nurse tried to open a va locking screw, the nurse accidentally opened the cortical screw that had been mixed in.The screw that was accidentally opened was used.The sales rep guessed that it was mistakenly put in the set in logistics.The surgery was completed successfully without any surgical delay.No further information is available.This report is for one (1) cortscr ø2.4 self-tap l14 tan.This is report 1 of 1 for complaint: (b)(4).
|
Product complaint#: (b)(4).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.Additional narrative: initial reporter occupation: reporter is a j&j employee.Device available for evaluation: 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.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.
|