Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent an osteosynthesis with tfna augmentation and the syringe kit in question for a trochanteric fracture of the femur.The surgeon injected the cement (2ml x 2 and 1ml x 2) into the syringe without no problems.When the surgeon tried to inject the 1ml cement into the syringe, the connection screw of the syringe broke.The broken part was stuck in the stop-cock and could not be removed.Therefore, the surgeon gave up on injecting, and the lack of cement was handled by pushing out cement with a plunger.The surgeon injected approximately 3.5ml cement into the femoral head.The surgery was completed successfully within 30 minutes delay.No further information is available.This report involves one traumacem(tm) v+ syringe kit - sterile.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6) medical center.Reporter is a j&j employee.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.
|