Model Number 209999 |
Device Problems
Output Problem (3005); Insufficient Information (3190)
|
Patient Problems
Fall (1848); Bone Fracture(s) (1870)
|
Event Date 10/24/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
|
|
Event Description
|
This pi is for the robot used in the primary procedure.Pt fractured their femur post-op and want to run the workflow.I believe the pt fractured their femur during physical therapy/during a fall.Patient plan and log files: (b)(6).Case type: tka.
|
|
Event Description
|
This pi is for the robot used in the primary procedure.Pt fractured their femur post-op and want to run the workflow.I believe the pt fractured their femur during physical therapy/during a fall patient plan and log files: (b)(6).Case type: tka.
|
|
Manufacturer Narrative
|
Reported event: an event regarding periprosthetic fracture involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that ¿pt fractured their femur post-op and want to run the workflow.I believe the pt fractured their femur during physical therapy/during a fall¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: not performed as no medical records were provided for review.Product history review review of the device history records associated with rio 857 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review a search of the complaint database under device identification pn 209999 reports no similar complaints for tha software - other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tha software - other.H3 other text : device not returned.
|
|
Search Alerts/Recalls
|