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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

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

Robot 539 creating cuts that do not match the plan.Post-op x-rays show notching and extended implants despite 5 degrees of flexion in the femur.Robot passing all pre-surgery checks.Need engineer to come make sure robot no major errors within robotic arm.No surgical delay.Case type / application: tka.Update 04/june/2021 (b)(6): as reported in case mps reported inaccurate cuts.Mps stated post-op x-rays are showing notching.Mps stated cuts are showing 2mm or less off when using the planar probe.Mps spoke with fse.

Event Description

(b)(6) creating cuts that do not match the plan.Post-op x-rays show notching and extended implants despite 5 degrees of flexion in the femur.Robot passing all pre-surgery checks.Need engineer to come make sure robot no major errors within robotic arm.No surgical delay.Case type / application: tka.Update 04/june/2021 wg: as reported in case mps reported inaccurate cuts.Mps stated post-op x-rays are showing notching.Mps stated cuts are showing 2mm or less off when using the planar probe.Mps spoke with fse.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection and foreign matter involving a mako tka 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: could not produce any accuracy problems through normal pre-surgery checks.With a deep dive of the robot i found a very small area on the j6 motor encoder glass that was producing bad signal.I replaced the glass.Found j6 joint encoder to be slightly dirty, so i cleaned it well.Also adjusted and cleaned j5, j4, and j3 encoder glasses.J1 and j2 showed to be within optimal operating range.Performed all necessary testing due to the encoder glass that was replaced and the others that were adjusted.After calibrations and testing, no more issues were found with the robot.Robot is 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 0 similar complaints for tka software - inaccurate resection.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
• MDR Report Key: 12092381
• MDR Text Key: 259178228
• Report Number: 3005985723-2021-00115
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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
• Device Lot Number: ROB539
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention