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

Model Number 209999

Device Problem Positioning Failure (1158)

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

Event Date 01/24/2023

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

It was reported that the following occurred with a mako unit "during a left medial unicompartmental mako pka case, once the surgeon put in the trial for the tibia, he mentioned the trial is more posterior and lateral than he had anticipated.The surgeon then concluded the holes for the tibial posts were more posterior and lateral than what he had planned.Before burring the tibia checkpoint and the burr checkpoint both passed.When the surgeon intended to remove the tibial trial, he had a hard time, which increased the surgery time by 5 minutes.He then anteriorized by 0.5mm and medialized by 1.5mm, and reburred using the robot.Once reburred, he was not satisfied with the result, hence he used a handheld power tool to burr the holes.This added another 10 minutes to the surgery time.".

Event Description

It was reported that the following occurred with a mako unit "during a left medial unicompartmental mako pka case, once the surgeon put in the trial for the tibia, he mentioned the trial is more posterior and lateral than he had anticipated.The surgeon then concluded the holes for the tibial posts were more posterior and lateral than what he had planned.Before burring the tibia checkpoint and the burr checkpoint both passed.When the surgeon intended to remove the tibial trial, he had a hard time, which increased the surgery time by 5 minutes.He then anteriorized by 0.5mm and medialized by 1.5mm, and reburred using the robot.Once reburred, he was not satisfied with the result, hence he used a handheld power tool to burr the holes.This added another 10 minutes to the surgery time.".

Manufacturer Narrative

Reported event an event regarding inaccurate resection involving a mako robotic arm was reported.The alleged failure mode was not confirmed as there has been no onsite inspection by a field service engineer.Method & results -product evaluation and results: a request for a field service engineer inspection was not made and the robot was not inspected as no service max case & work order exists.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there are other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed as there has been no onsite inspection by a field service engineer.If a field service inspection is requested, further investigation will be completed on this issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16405879
• MDR Text Key: 310242655
• Report Number: 3005985723-2023-00038
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/22/2023

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: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/22/2023
• 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