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

Model Number 219999

Device Problems Output Problem (3005); Unintended Movement (3026)

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

Event Date 09/28/2022

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

There was a bumped base array issue after cutting the anterior, anterior chamfer, and posterior cuts but before the tibia cut (unable to pass the saw blade without re-registering the robot).After all cuts were made and during the second round of cuts - bone was removed on posterior cut of femur.The surgeon claimed the anterior chamfer cut was off but was satisfied with the femur fit and was able to press fit like originally planned.Planar probe was not used but was offered.Case type / application: tka.

Manufacturer Narrative

An event regarding non functional involving a mako robotic arm was reported.The event was confirmed.Method & results problem reproduced? yes.Trouble shooting notes: none.Work performed: performed pm per service manual.Ran all tests and calibrations per the service manual.Adjusted j5 and j6 transmission cables.Also, adjusted j2 bump stop.System 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: review of the device history records indicate rob1285 devices were manufactured and accepted into final stock on 9/9/2020 with no relevant reported discrepancies.-complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was 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.H3 other text : device not returned.

Event Description

There was a bumped base array issue after cutting the anterior, anterior chamfer, and posterior cuts but before the tibia cut (unable to pass the saw blade without re-registering the robot).After all cuts were made and during the second round of cuts - bone was removed on posterior cut of femur.The surgeon claimed the anterior chamfer cut was off but was satisfied with the femur fit and was able to press fit like originally planned.Planar probe was not used but was offered.Case type / application: tka.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: susan kinney ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15624064
• MDR Text Key: 303263491
• Report Number: 3005985723-2022-00131
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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