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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Malposition of Device (2616)

Patient Problem Ambulation Difficulties (2544)

Event Date 09/28/2020

Event Type  Injury  

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)(6): last 3 cases have resulted in notching.Mps reviewed all 3 plans after case completion and confirmed that the notching issues weren't related to the planned implant placement, patient anatomy (i.E., scan date versus surgery date), robot's inherent error of 2mm/2degrees, etc.I confirmed with the mps that all pre-surgery checks passed prior to each case.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection and 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: no issues found, rerun homing constants and re calibrated.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 rob424 was inspected on 31 aug 2016 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob424 shows 2 similar complaints for tka software - inaccurate resection.The complaint record numbers are: (b)(4), (b)(4).Conclusions: the alleged failure mode was not confirmed.Additional information such as return of the crisis logs, patients session files, post op follow up notes and post op x-rays.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.

Event Description

Case: last 3 cases have resulted in notching.Mps reviewed all 3 plans after case completion and confirmed that the notching issues weren't related to the planned implant placement, patient anatomy (i.E., scan date versus surgery date), robot's inherent error of 2mm/2degrees, etc.I confirmed with the mps that all pre-surgery checks passed prior to each case.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10725719
• MDR Text Key: 212695270
• Report Number: 3005985723-2020-00317
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other