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

Model Number 209999

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 10/23/2019

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

Case number: (b)(4) - mps (b)(6) reported angle discrepancy failure in j5.Surgery was not completed robotically.Update: case type: tka.Any surgical delay? (no delay, < 15 min, < 30 min, = 30 min): yes <30 min.Was the case cancelled? (yes/no) no.Was procedure completed successfully? (yes/no) yes.Was procedure completed manually? (yes/no ¿ explain) yes, robotic failure.Occurred during intra-op rio registration.Bone registration and joint balancing were complete, but no resections were made with the rio.Was the patient under anesthesia at the time of the issue? (yes/no) yes.

Manufacturer Narrative

Mps reported angle discrepancy failure in j5.Surgery was not completed robotically.Device evaluation and results: per (b)(4): error was on j6 not j5.Cleaned j6 encoder, kin-cal both sides.Verified robot no longer has error.Completed all testing and verifications.System investigation completed successfully as per service manual.All system checks and tests passed.Product history review: a review of device history records shows that on 06/26/2012 1 device was inspected and 1 device was placed on: npr 12-05-0098, npr 12-05-0038.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 201903 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.

Event Description

Case number: (b)(4).Reported angle discrepancy failure in j5.Surgery was not completed robotically.Update: case type: tka.Any surgical delay? (no delay, < 15 min, < 30 min, = 30 min): yes <30 min.Was the case cancelled? (yes/no) no.Was procedure completed successfully? (yes/no) yes.Was procedure completed manually? (yes/no ¿ explain).Yes, robotic failure occurred during intra-op rio.Registration.Bone registration and joint balancing were complete, but no resections were made with the rio.Was the patient under anesthesia at the time of the issue? (yes/no) yes.

• 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: 9320788
• MDR Text Key: 184459194
• Report Number: 3005985723-2019-00799
• 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: 01/20/2020

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: 10/23/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 12/24/2019
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization