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

Catalog Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

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

As reported by mps: "surgeon completed an off label conversion of a (mako) unicondylar knee replacement to a total knee replacement.The surgeon reported that the popliteus was cut while using the robot to make cuts.".

Event Description

As reported by mps: "surgeon completed an off label conversion of a (mako) unicondylar knee replacement to a total knee replacement.The surgeon reported that the popliteus was cut while using the robot to make cuts.".

Manufacturer Narrative

An event regarding inaccurate resection involving a mako robotic arm was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: there have been other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 3.0 RIO® ROBOTICARM - 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18660025
• MDR Text Key: 334772032
• Report Number: 3005985723-2024-00019
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• 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: 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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): Required Intervention