MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problems Positioning Failure (1158); Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)

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

Event Date 03/09/2021

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

This pi is for case 2 of 3."distal and anterior chamfer cuts were off (implant was sitting off bone) on lateral femur in 3 out of 4 cases." no surgical delay.Case type / application: tka.

Event Description

This pi is for case 2 of 3."distal and anterior chamfer cuts were off (implant was sitting off bone) on lateral femur in 3 out of 4 cases." no surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection 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 fully provided.Crisis logs have been provided but both crisis logs and patient session files are required to evaluate software failures.A review of similar complaints related to inaccurate cuts have noted the following tips to resolve ant potential issues with the surgeons cutting technique.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.The field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: completed kinematic calibration on left and right surgical sides.Confirmed all transmission cable at nominal tension.Verified arm accuracy has passing results.All required testing has passing results.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 rob915 was inspected on 05 june 2019 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob915 shows 0 similar complaints for tka software - inaccurate resection.Conclusions: the alleged failure mode was not confirmed or reproduced by an field service engineer however, the fse conducted a kinematic calibration on left and right surgical sides, confirmed all transmission cables were at nominal tension and verified arm accuracy had passing results.In addition to this a pm was conducted.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the patient session files are required to complete a full investigation for determining root cause.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: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11618270
• MDR Text Key: 243905868
• Report Number: 3005985723-2021-00058
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other