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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTAXIC DEVICE, ROBOICS Back to Search Results
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.

 
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Brand NameANSPACH EMAX 2 PLUS BURR MOTOR
Type of DeviceSTEREOTAXIC 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 Key6033111
MDR Text Key57576968
Report Number3005985723-2016-00322
Device Sequence Number1
Product Code OLO
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
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 Received10/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number110940
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
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 TREATMENT DATA
Date Received: 10/17/2016 Patient Sequence Number: 1
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