MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH® EMAX2 PLUS MOTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number EMAX2PLUS

Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/17/2018

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

During mako pka case with mr (b)(6), we experienced two non functional emax2plus anspach motors, error e5 after troubleshooting this error by using a third anspach motor we encountered an issue during the burring screen where, after having burred half th femur, we removed the burr from the haptic field and placed into holster position.When we brought the burr back into the surgical volume we noticed that the burr image did not show.We exited the burr screen returning to the ¿check results¿ page that precedes the burring screen and upon placing the burr tip into the white circle on the end effector array, we received no result despite the arrays being visible.It was noted that there was no interference with robot array.The issue was rectified by re registering the robot and verifying.After this there were no further issues.The case was competed without adverse effect despite time being added to procedure.Surgeon was satisfied with end result.

Event Description

During mako pka case with mr stoney, we experienced two non functional emax2plus anspach motors, error e5.After troubleshooting this error by using a third anspach motor we encountered an issue during the burring screen where, after having burred half th femur, we removed the burr from the haptic field and placed into holster position.When we brought the burr back into the surgical volume we noticed that the burr image did not show.We exited the burr screen returning to the ¿check results¿ page that precedes the burring screen and upon placing the burr tip into the white circle on the end effector array, we received no result despite the arrays being visible.It was noted that there was no interference with robot array.The issue was rectified by re registering the robot and verifying.After this there were no further issues.The case was competed without adverse effect despite time being added to procedure.Surgeon was satisfied with end result.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor e5 error.Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was not confirmed.-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 catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding anspach emax 2 plus burr motor e5 error failure of p/n: emax2plus, s/n: (b)(4).There have been no other similar events for the referenced serial number.Conclusions: the anspach emax 2 plus burr motor is an oem device.Upon receipt, the anspach emax 2 plus burr motor was bench evaluated by (b)(4) (sr.Technician, robotics) and the reported event was not 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.

• Brand Name: ANSPACH® EMAX2 PLUS MOTOR
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7518715
• MDR Text Key: 108898580
• Report Number: 3005985723-2018-00294
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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: EMAX2PLUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization