MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Electrical /Electronic Property Problem (1198); Inappropriate Tactile Prompt/Feedback (4023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

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; device not returned.

Event Description

Mps reported arm struggling to get into haptics and then shaking out of the haptics during cuts.Update: surgical delay: "under a minute", right side, tka.

Event Description

Mps reported arm struggling to get into haptics and then shaking out of the haptics during cuts.Update: surgical delay: "under a minute", right side, tka.

Manufacturer Narrative

Reported event: an event regarding electrical failure involving a mako robotic arm was reported.The event was not confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: after performing several transmission tests, friction tests, phase check tests and completing a field haas test the reported problem was not able to be duplicated.All verification testing indicated the transmission cables were adjusted and torqued to their ideal factory settings.All bump stops were good with the exception of the right side of j2 needing to be reset.Both left and right side j2 bump stops were set to the correct degrees on the previous day.All verification testing passed successfully.All maintenance, adjustment and testing steps were performed following the service manual.(b)(6) is ready to be returned to service.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected on 14/11/2017 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 0 additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was not confirmed.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10991999
• MDR Text Key: 220939054
• Report Number: 3005985723-2020-00383
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• 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
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR