MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209999

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Injury (2348)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

As part of 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

Dr.(b)(6) asked dr.(b)(6) to revise one of his patients previous mako patellofemoral cases to a mako tka.Dr.(b)(6) doesn¿t do tkas nor is he trained on the procedure so dr.(b)(6) did the case.Case type: tka.

Manufacturer Narrative

Reported event: an event regarding revision involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that "dr.(b)(6) asked dr.(b)(6) to revise one of his patients previous mako patellofemoral cases to a mako tka.Dr.(b)(6) doesn¿t do tkas nor is he trained on the procedure so dr.(b)(6) did the case." method & results: device history review: review of the device history records associated with rio 383 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for tka software - revision.The complaint record numbers are: (b)(4).Conclusion: the failure could not be determined 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 tka software - revision.H3 other text : device not returned.

Event Description

Dr.(b)(6) asked dr.(b)(6) to revise one of his patients previous mako patellofemoral cases to a mako tka.Dr.(b)(6) doesn¿t do tkas nor is he trained on the procedure so dr.(b)(6) did the case.Case type: tka.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8757836
• MDR Text Key: 149934646
• Report Number: 3005985723-2019-00486
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization