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

Model Number 219999

Device Problem Unintended Movement (3026)

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

Event Date 01/29/2021

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

Case number: (b)(4): (b)(6) reported arm shaking/vibrating abnormally during posterior chamfer cuts.Already spoke with (b)(6).This issue occurred in a case last week and again today.When the arm was shaking/vibrating, the mics never lost power nor were there any error messages on the screen related to patient positioning relative to the robot.

Event Description

This pi is for 'the case last week.'.Case number: (b)(4): mps (b)(6) reported arm shaking/vibrating abnormally during posterior chamfer cuts.Already spoke with fse (b)(6).This issue occurred in a case last week and again today.When the arm was shaking/vibrating, the mics never lost power nor were there any error messages on the screen related to patient positioning relative to the robot.

Manufacturer Narrative

Reported event.An event regarding unintended movement involving a mako robotic arm was reported.The event was not confirmed.Method & results.-product evaluation and results: the field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: adjusted j5 transmission cable to nominal value.Verified all joints are within nominal range of tension.Cleaned camera lenses.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 rob1111 was inspected on 27/02/2020 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: rob1111 shows 0 additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was not 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.

• 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: 11362154
• MDR Text Key: 256740164
• Report Number: 3005985723-2021-00028
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Device Lot Number: ROB1111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other