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

Model Number 209999

Device Problems Application Program Problem: Parameter Calculation Error (1449); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2019

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

Femoral trials are sitting proud of distal and anterior chamfer cuts for a pressfit knee.Surgeon is double passing post/ant/distal cuts when advised.Planar probe is reading 1mm proud after initial cuts, when cuts are revisited will only respect ~0.2-0.3 additional mm.This has occurred consistently with this surgeon at this site for the last month.Unsure if this is due to surgeon technique or system needs to be recalibrated? case type: tka.Surgical delay: =15 minutes.Update: patient was under anesthesia.

Manufacturer Narrative

Reported event: it was reported " femoral trials are sitting proud of distal and anterior chamfer cuts for a pressfit knee.Surgeon is double passing post / ant / distal cuts when advised.Planar probe is reading 1mm proud after initial cuts, when cuts are revisited will only respect ~0.2-0.3 additional mm.This has occurred consistently with this surgeon at this site for the last month.Unsure if this is due to surgeon technique or system needs to be recalibrated? case type: tka.Surgical delay: 15 minutes.Update: patient was under anaesthesia¿.Method & results: product evaluation and results: the session and vp log data from the case was reviewed.An analysis of the femur checkpoint values, femur registration values, probe check values, rio registration and verification values, bone preparation checkpoints values, and cutting tool location was completed.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.The rio cut all five femoral planes within 0.4mm of target, based on the burrlist plane analysis.However, it was noted that four out of the five femoral cuts were rotated in this analysis.Please see a list of best cutting practices below.This is a list of items that we have learned can lead to similar inaccuracies as seen here.These cutting technique best practices indicate which can specifically help alleviate flexed/extended resections.1.Approach bone slowly.2.Let the saw do the work, don't push / pull off plane (light touch).3.Double-pass distal cut (and any hard bone).4.On final pass, ensure blade is powered on before contacting bone.5.Do not change leg flexion or tilt between femoral cuts.Product history review: a review of device history records shows that (b)(6) was inspected on 28 november 2018 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn: 219999, (b)(6) reports no similar complaints related to the failure in this investigation.Conclusions: the failure was reviewed through return of the provided log / session files.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.

Event Description

Femoral trials are sitting proud of distal and anterior chamfer cuts for a pressfit knee.Surgeon is double passing post / ant / distal cuts when advised.Planar probe is reading 1mm proud after initial cuts, when cuts are revisited will only respect ~0.2-0.3 additional mm.This has occurred consistently with this surgeon at this site for the last month.Unsure if this is due to surgeon technique or system needs to be recalibrated? case type: tka.Surgical delay: 15 minutes.Update: patient was under anesthesia.

• 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: 8822134
• MDR Text Key: 152059911
• Report Number: 3005985723-2019-00533
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• 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?: Yes
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other