MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 12/20/2017

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

Mics would not work with rio set up.Did a cutter reset, then arm software reset, and a soft reboot, then 4 hard reboots and sterile homing of the rio and it would not work.The same thing happened when i switched hand pieces.Tka case delayed for approximately 20 minutes.Procedure was completed manually with a manual stryker knee.

Event Description

Mics would not work with rio set up.Did a cutter reset, then arm software reset, and a soft reboot, then 4 hard reboots and sterile homing of the rio and it would not work.The same thing happened when i switched hand pieces.Tka case delayed for approximately 20 minutes.Procedure was completed manually with a manual stryker knee.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.The handpiece did not work.Device history records indicate 25 devices were manufactured under lot k09gr and 25 including 4202052 were accepted into final stock on (b)(6) 2017.A review of complaints related to parts in lot number k09gr, p/n 209063 shows no other complaint related to the failure in this investigation.Visual inspection revealed no physical damage of unit.Dimensional inspection was not completed functional inspection clearly shows the failure of the device.Material analysis was not completed because the failure was functional.Upon receiving, mics worked intermittently when cable was exercised, turning on properly when trigger was pulled and off when cable was moved.Shortly after, mics stopped working.The handpiece driver electronics (commutation board) communicate with the handpiece trigger.A failure of this communication will break the process that allows the trigger command to result in the motor spinning.A review of stryker¿s nc/capa database indicated that (b)(4) are associated with the failure mode reported in this event.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7174583
• MDR Text Key: 97083945
• Report Number: 3005985723-2018-00021
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: 4202042 / 42010417
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization