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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2019

Event Type  malfunction  

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

X-ray film shown not acceptable cup position which system shown 41/19 cup plane.Case type: tka.

Event Description

X-ray film shown not acceptable cup position which system shown 41/19 cup plane.Case type: tka.Update: "patient was under anesthesia.".

Manufacturer Narrative

Reported event: an event regarding software error involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported ¿x-ray film shown not acceptable cup position which system shown 41/19 cup plane.¿ method & results: product evaluation and results: review of the provided session logs/case files provided the following information: areas of investigation: checkpoints; pelvic registration; post-op x-ray.Checkpoints: the recorded checkpoint value is not acceptable.The checkpoint value is 24.5mm during impaction.Pelvic registration: outlier rejection was triggered in both attempts.2 outliers were rejected in the first attempt and 4 outliers in the last attempt.Surgeon passed all verification points except one in the last attempt.For the first attempt, the initial registration result shows rotational error based on the significantly moved fossa points (point 15 and 16) and the two horseshoe groups.The rim points also rotated into the osteophytes.After fine (surface) registration, the points significantly rotated compared to the initial registration result.The surface points collected seems not covering enough feature to lock rotation and resulting in the lower rms error.For the last attempt, the initial registration result shows rotational error too based on the moved fossa points (point 15 and 16).After fine (surface) registration, the points also significantly changed compared to the initial registration result.Larger inclination change was observed that the anterior horseshoe points (point 1-4) moved superiorly.In conclusion, both registrations demonstrated rotational error, which might be due to avoiding the superior osteophytes.In the last attempt, significant inclination change was observed, which indicates bad registration that could lead to noticeable inclination and version errors.Post-op x-ray: based on the post-op x-ray, the inclination is only 15 degrees which is far away from the reported 41 degrees.Product history review: review of the device history records associated with rio 220 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification (b)(4) reports similar complaints for tha software - software error.The complaints are pr: (b)(4).Conclusions: based on the above analysis, the bone registration contributes to the error of cup orientation.The logged checkpoint values in cup impaction is off as well, which indicates the array was bumped during the case.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 (b)(4) reports no records related to tha software - software error.

• 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: 9280346
• MDR Text Key: 165122988
• Report Number: 3005985723-2019-00790
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization