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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 STEREOTACTIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTACTIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 110940
Device Problems Break (1069); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2016
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 performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio). During the case the anspach burr motor malfunctioned. The anspach motor was exchanged with a replacement anspach motor, which then also malfunctioned. The motor was exchanged for a third replacement motor. The case was then completed successfully.

 
Manufacturer Narrative

Based on the results of investigation. Reported event: anspach emax 2 plus burr motor overheated. Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was 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 overheated failure of p/n: 110940, sn: (b)(4). There has been (1) other similar event for the referenced serial number (pr id: (b)(6)). Trend request for this part number has been submitted (trend request #737). 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 james moll (engineer, r&d robotics) 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 #737 has been initiated to continue to monitor for events related to this device.

 
Event Description

The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio). During the case the anspach burr motor malfunctioned. The anspach motor was exchanged with a replacement anspach motor, which then also malfunctioned. The motor was exchanged for a third replacement motor. The case was then completed successfully.

 
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Brand NameANSPACH EMAX 2 PLUS BURR MOTOR
Type of DeviceSTEREOTACTIC 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 Key5639143
MDR Text Key44673553
Report Number3005985723-2016-00146
Device Sequence Number1
Product Code OLO
Combination Product (Y/N)N
Reporter Country CodeUS
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 04/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2016
Is This An Adverse Event Report? No
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 Received05/23/2016
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 TREATMENT DATA
Date Received: 05/06/2016 Patient Sequence Number: 1
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