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

Catalog Number 110940

Device Problems Device Displays Incorrect Message (2591); Insufficient Information (3190)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

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 was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when an error messaged displayed during the burring phase.In addition to this error message, the camera head was not stable enough to hold its position, causing the camera to swing in one direction making it difficult to achieve visualisation of all arrays.These errors added an additional 10-20 minutes of anaesthetic time to the case while troubleshooting and as the patient was consented to bilateral medial knee replacements, caused the surgeon to abandon case after completing the first (left) knee.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: the 110940 ¿ mako anspach motor with reported event of "cutting system motor lock e2".Method & results: the common causes for e2 errors include: -burr lock engaged.-stuck burr (in tissue).-bad bearings (no movement) in motor or hd long.-repeated trigger engagements during a 2-second safety lockout (this prolongs the 2 second lockout, and educes the failure).The specific cause for this event could not be verified as the product for this investigation was not returned.A pm (preventative maintenance) was executed shortly after this event and no issues were identified the system passed per gsp # (b)(4).-device history review: not performed as the anspach emax 2 plus burr motor is an oem product.-complaint history review: a complaint history review was completed using serial number (b)(4).There have been no other similar events for the referenced serial number.Conclusions: the specific cause for this event could not be verified as the product for this investigation was not returned.A pm (preventative maintenance) was executed shortly after this event and no issues were identified the system passed.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.The device was not returned for evaluation.

Event Description

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when an error messaged displayed during the burring phase.In addition to this error message, the camera head was not stable enough to hold its position, causing the camera to swing in one direction making it difficult to achieve visualisation of all arrays.These errors added an additional 10-20 minutes of anaesthetic time to the case while troubleshooting and as the patient was consented to bilateral medial knee replacements, caused the surgeon to abandon case after completing the first (left) knee.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6150671
• MDR Text Key: 61612427
• Report Number: 3005985723-2016-00417
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/14/2017

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
• Device Lot Number: ROB399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 07/14/2017
• 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