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

Catalog Number 209999

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

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

Event Date 11/23/2016

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

Prior to a total hip arthroplasty procedure, the mics handpiece was very warm and was giving a temperature error when checking mics status check (due to it having to be one-trayed).After allowing the mics to cool longer about 25 minutes we rechecked the mics status check and got a green code.After opening the tha software a burr status mismatch call service error code occurred.The surgeon completed the case manually.

Manufacturer Narrative

Reported event: an event regarding a connection error involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio (b)(4) found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999), the complaint databases were reviewed from 2011 to present for similar reported events regarding a connection error.There were two other reported events, (b)(4).Conclusion: an analysis of the vplogs and crisis logs was performed.The logs show that an issue with the cable connection and anspach commutation board prevented both cutting systems in tha and pka cases, respectively, from enabling as indicated by the cable connection error and anspach commutation error.Gsp (b)(4) states, "could not duplicate reported issue.Successfully performed mics status check on both mics handpieces.Successfully performed cutter test on both mics handpieced.The second mics tested had a loud squealing noise but passed.Recommended to mps to replace it.Successfully performed presurgery checks.System is ready for clinical use".

Event Description

Prior to a total hip arthroplasty procedure, the mics handpiece was very warm and was giving a temperature error when checking mics status check (due to it having to be one-trayed).After allowing the mics to cool longer about 25 minutes we rechecked the mics status check and got a green code.After opening the tha software a burr status mismatch call service error code occurred.The surgeon completed the case manually.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTACTIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6145945
• MDR Text Key: 61465077
• Report Number: 3005985723-2016-00411
• Device Sequence Number: 1
• Product Code: OLO
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization