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

Catalog Number 209999

Device Problem Calibration Problem (2890)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

During the case the pt registration would not pass due to the segmentations rotation being off, this was making the bone model turn to its side.This cause the surgeon guide pattern to align over the side of the femur instead of the anterior like it should have.Case was cancelled, pt will have to return on a later date for the tka.Case type / application: tka.

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.

Manufacturer Narrative

Reported event an event regarding segmentation issue involving a mako tka software was reported.The event was confirmed.Method & results -product evaluation and results: based on a review of the scans provided by the mps, 1.Patient¿s leg was not rotated correctly when they were scanned 2.The motion rod was placed underneath the patient¿s improperly rotated leg rather than on the lateral side best practice is for the mps to review the scan before submitting to the segmentation team.-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 no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was confirmed to have been caused by user error.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

During the case the pt registration would not pass due to the segmentations rotation being off, this was making the bone model turn to its side.This cause the surgeon guide pattern to align over the side of the femur instead of the anterior like it should have.Case was cancelled, pt will have to return on a later date for the tka.Case type / application: tka.

• 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: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17478093
• MDR Text Key: 320574652
• Report Number: 3005985723-2023-00125
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Device Lot Number: ROB161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 108 KG