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

Catalog Number 110940

Device Problems Mechanical Problem (1384); Temperature Problem (3022)

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

Event Date 10/01/2016

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

The surgeon performed a partial knee arthroplasty procedure on using the robotic arm interactive orthopedic system (rio).During the case, the software repeatedly displayed an "e6" error for motor overheating.The surgery was completed however it was delayed for 60 minutes.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor loss during mako pka bone preparation."software repeatedly displayed an "e6" error for motor overheating.Method and results: device evaluation and results: no device inspection could be completed as the device was not returned for evaluation.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 anspach emax 2 plus burr motor loss during mako pka bone preparation."software repeatedly displayed an "e6" error for motor overheating failure of p/n: 110940, s/n: (b)(4).There have been no other similar events for the referenced serial number.Trend request for this part number has been submitted (trend request #737).Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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 #737 has been initiated to continue to monitor for events related to this device.Device was not returned for evaluation.

Event Description

The surgeon performed a partial knee arthroplasty procedure on using the robotic arm interactive orthopedic system (rio).During the case, the software repeatedly displayed an "e6" error for motor overheating.The surgery was completed however it was delayed for 60 minutes.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• Type of Device: STEREOTAXIC DEVICE, ROBOICS
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6033111
• MDR Text Key: 57576968
• Report Number: 3005985723-2016-00322
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: Initial,Followup
• Report Date: 10/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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