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

Model Number 209999

Device Problems Contamination /Decontamination Problem (2895); Noise, Audible (3273)

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

Event Date 08/31/2020

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.

Event Description

Mps reported loud noise in j4 and j5 during reaming.Mps has also noticed some blue fluid leaking under the rob.

Manufacturer Narrative

Reported event: mps reported loud noise in j4 and j5 during reaming.Mps has also noticed some blue fluid leaking under the rob.Product inspection: the field service engineer reported: problem reproduced? yes.Work performed: mps nick miller reported a loud noise in j4 & j5 during reaming of hip cases.During investigation, found that actually, j6 transmission cable tension was out of spec at 26 degrees phase lag (out of spec).Re-torqued j6 transmission cable to spec to 16.3 degrees phase lag (in spec).After re-torqueing and tightening j6 transmission cables, there was no audible noise coming from the system.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: a review of device history records shows that on 11/29/2012, (b)(6) device was manufactured.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.

Event Description

Mps reported loud noise in j4 and j5 during reaming.Mps has also noticed some blue fluid leaking under the rob.

• 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: 10574504
• MDR Text Key: 208159928
• Report Number: 3005985723-2020-00302
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other