MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR; STEREOTACTIC DEVICE

Catalog Number 110940

Device Problems Electrical /Electronic Property Problem (1198); Failure to Fire (2610)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/14/2015

Event Type  Injury  

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

The surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio).During pre-surgery check, the robot failed during burr check while the surgeon was prepping and making incision.There was a case delay of approximately one hour.The surgery was completed using manual instruments.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor has had a reported event of "motor has an electrical fault." method and results: device evaluation and results: per gsp case (b)(4), inspected per tsp-0011 anspach emax 2 plus burr motor had a 10 beep fail on the console.The reported event has been confirmed.The anspach emax 2 plus burr motor is an oem device and was returned to the supplier.Device history review: not performed as the anspach emax 2 plus burr motor is an oem product.Complaint history review: based on the device identification, the (b)(6) complaint databases were reviewed from 2011 to present for similar reported events regarding the anspach not cutting when they tried the hospital's anspach handpiece there have been no other events for the referenced serial number.Trend request #860 for this part number has been submitted.Conclusions: the anspach motor is an oem device.Upon receipt, the device was evaluated per tsp-0011 anspach emax 2 plus burr motor and the reported event was confirmed.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.Trend request #860 has been initiated to continue to monitor for events related to this device.

Event Description

The surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio).During pre-surgery check, the robot failed during burr check while the surgeon was prepping and making incision.There was a case delay of approximately one hour.The surgery was completed using manual instruments.

Event Description

The surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio).During pre-surgery check, the robot failed during burr check while the surgeon was prepping and making incision.There was a case delay of approximately one hour.The surgery was completed using manual instruments.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• Type of Device: STEREOTACTIC DEVICE
• 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: 5138098
• MDR Text Key: 27911310
• Report Number: 3005985723-2015-00186
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 04/21/2017

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: 110940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2016; 04/21/2017
• 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): Required Intervention