MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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)(4), rob523: mps, (b)(6), reported robot off cutting to 5mm deep.Reverted to manual.Case type: tka.Surgical delay: 5 hours.Surgery was not completed robotically.Update: "was there patient involvement? any patient harm? yes need to revert to manual and use 5mm distal augments.Any surgical delay? 5hours.Was the case cancelled? no.Was procedure completed successfully? yes but not to plan.Was procedure completed manually? yes.Was the patient under anesthesia at the time of the issue? yes.Which cuts were inaccurate? only one cut preformed and the distal femur.How was the cut inaccurate? 5mm deep.What is the estimated discrepancy mentioned in the complaint? (pka - mm) 5mm.When was the issue noticed? bone preparation.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.".

Event Description

Case number: (b)(4), rob523: mps, tara brett, reported robot off cutting to 5mm deep.Reverted to manual.Case type: tka.Surgical delay: 5 hours.Surgery was not completed robotically.Update: "was there patient involvement? any patient harm? yes need to revert to manual and use 5mm distal augments.Any surgical delay? 5hours.Was the case cancelled? no.Was procedure completed successfully? yes but not to plan.Was procedure completed manually? yes.Was the patient under anesthesia at the time of the issue? yes.Which cuts were inaccurate? only one cut preformed and the distal femur.How was the cut inaccurate? 5mm deep.What is the estimated discrepancy mentioned in the complaint? (pka - mm) 5mm when was the issue noticed? bone preparation.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.".

Manufacturer Narrative

It has been confirmed that stryker reference numbers 3005985723-2019-00736 and 3005985723-2019-00739.Are related to the same procedure and patient that were received and entered to our complaint system from two different sources.This event, 3005985723-2019-00726, is being cancelled as it is a duplicate event.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9174530
• MDR Text Key: 175450023
• Report Number: 3005985723-2019-00726
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR