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

Model Number 219999

Device Problems Positioning Failure (1158); Complete Loss of Power (4015)

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

Event Date 11/04/2020

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.Device not returned.

Event Description

Case number: (b)(4): mps reported arm dropping out of haptics during straight cuts.Fse already notified.Surgery will be completed robotically.

Manufacturer Narrative

Reported event: mps reported arm dropping out of haptics during straight cuts.Fse already notified.Surgery will be completed robotically.Method & results: product evaluation and results: the factory service engineer reported: the j2 bump stops were slightly off.Adjust to factory specifications.Run gravity on knee and mics.Verify gravity on the mics hand piece.Clinician review: no medical records were received for review with a clinical consultant.Review of the device history records indicate (b)(6) was manufactured and accepted into final stock on 5/12/2020 with no relevant reported discrepancies.Complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: (b)(6) shows 0 additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was 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.

Event Description

Case number: (b)(4): mps reported arm dropping out of haptics during straight cuts.Fse already notified.Surgery will be completed robotically.

• 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: 10918566
• MDR Text Key: 220246842
• Report Number: 3005985723-2020-00374
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other