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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

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

Event Date 05/14/2021

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.

Event Description

Case number: (b)(4): mps reported inaccurate cuts and rio registration issues.Mps was having difficulty passing sawblade checkpoint, re-registering robot, and green not going away during bone prep.Mps had to shutdown twice to be able to pass rio registration.Mps confirmed no arrays were bumped.This has occurred on multiple on another case previously reported.Mps reported this occurred in a second case: "the issue we were having with our robot has hopefully been resolved.We had a pka case on the previous friday ((b)(6)) in which everything was completed robotically, but we did have to shut down the robot mid case to resolve a similar error.After the shutdown, the case was completed without a hitch.There was not a surgical delay after the shutdown.Patient identifiers are unavailable.".

Event Description

Case number: (b)(4): mps reported inaccurate cuts and rio registration issues.Mps was having difficulty passing sawblade checkpoint, re-registering robot, and green not going away during bone prep.Mps had to shutdown twice to be able to pass rio registration.Mps confirmed no arrays were bumped.This has occurred on multiple on another case previously reported.Mps reported this occurred in a second case: "the issue we were having with our robot has hopefully been resolved.We had a pka case on the previous friday (may 14) in which everything was completed robotically, but we did have to shut down the robot mid case to resolve a similar error.After the shutdown, the case was completed without a hitch.There was not a surgical delay after the shutdown.Patient identifiers are unavailable.".

Manufacturer Narrative

Reported event an event regarding inaccurate values/visuals involving a mako pka software was reported.The event was not confirmed.Method & results product evaluation and results: review of the case session files was not performed as case session data was not provided.The field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: reported problem ¿ bone not disappearing during bone prep.J6 joint angles inconsistent errors.Observation ¿ unable to reproduce the joint angles inconsistent errors.Action taken ¿ cpci replaced in order to fix the bone not disappearing issue.Original f17 computer transferred to new cpci.J6 encoders cleaned.J6 read head signals optimized.System ready for clinical use 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 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 1 similar complaints for pka software - inaccurate values/visuals.The complaint record numbers are: (b)(4).Conclusions: the alleged failure mode was not reproduced through an onsite inspection carried out by a field service engineer however the system was optimized for clinical use.In addition the failure could not be confirmed as the required log/session files were not made available for evaluation.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 h3 other text : device not returned.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 11986145
• MDR Text Key: 255823666
• Report Number: 3005985723-2021-00100
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other