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

Model Number 219999

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/11/2021

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

Mps reported green not disappearing in cuts.During a tka case, green bone was not disappearing with cuts.Mps shutdown and upon rebooting got a software error.Already spoke with fse.Requested logs.Surgery not completed robotically.

Event Description

Mps reported green not disappearing in cuts.During a tka case, green bone was not disappearing with cuts.Mps shutdown and upon rebooting got a software error.Already spoke with fse.Requested logs.Surgery not completed robotically.

Manufacturer Narrative

Reported event.An event regarding software error 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 provided.The field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: removed covers and inspected.Ran transmission, phase check, find friction, and optical compliance, all nominal.Re-installed tha and tka software applications.Robot was in great shape, minor cable tensioning.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 rob1083 was inspected on 27 jan 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: rob1083 shows 0 similar complaints for tka software - software error.Conclusions: the alleged failure mode was not confirmed through onsite inspection carried out by the field service engineer and the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the 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: 11217432
• MDR Text Key: 242411045
• Report Number: 3005985723-2021-00011
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other