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

Model Number 209999

Device Problems Material Deformation (2976); Output Problem (3005)

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

Event Date 09/30/2019

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

(b)(4) - mps (b)(6) reported 2 mics failures during case and unable to pass rio verification.Case type: tka.Surgery was not completed robotically.Update: surgical delay: 30 min."had to repeat twice to capture but he was moving very quickly through this step.There were osteophytes.".

Manufacturer Narrative

Reported event: case number: (b)(4), (b)(6) - mps bo reeder reported 2 mics failures during case and unable to pass rio verification.Case type: tka surgery was not completed robotically.Update: surgical delay: 30 min product inspection: product inspection could not be performed as the product was not available for evaluation.Product history review: product history review could be completed as the product was not returned and lot number was not provided.Complaint history review complaint history review could no be completed as the product was not returned and lot number was not provided.Conclusion the event could not be confirmed as the product was not returned.Corrective action/prev entive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc 1414517 and capa 1450904.H3 other text : device not returned.

Event Description

Case number: (b)(4), (b)(6) - mps bo reeder reported 2 mics failures during case and unable to pass rio verification.Case type: tka.Surgery was not completed robotically.Update: surgical delay: 30 min "had to repeat twice to capture but he was moving very quickly through this step.There were osteophytes".

• 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: 9151427
• MDR Text Key: 175448931
• Report Number: 3005985723-2019-00717
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization