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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; STEROTAXIC DEVICE, ACCESSORY
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MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR; STEROTAXIC DEVICE, ACCESSORY Back to Search Results
Catalog Number 110940
Device Problems Device Emits Odor (1425); Overheating of Device (1437); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2014
Event Type  malfunction  
Event Description
The surgeon was performing a bilateral knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.During the case, the burr motor began smoking and lost power.
 
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.Evaluation of the returned motors is ongoing.A supplemental report will be filed if additional results are obtained.
 
Manufacturer Narrative
Reported event: anspach emax 2 plus burr motor smokes and has loss of power.The event was confirmed.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 overheating failure of p/n 110940 s/n: (b)(4).There have been no other events for the referenced serial number.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 device was evaluated per tsp-0011 anspach emax 2 plus burr motor and the reported event was confirmed.
 
Event Description
The surgeon was performing a bilateral knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.During the case, the burr motor began smoking and lost power.
 
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Brand Name
ANSPACH EMAX 2 PLUS BURR MOTOR
Type of Device
STEROTAXIC DEVICE, ACCESSORY
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
jonathan reeves
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key4528939
MDR Text Key5506094
Report Number3005985723-2015-00018
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2015
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
Date Manufacturer Received01/20/2015
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 Sequence Number1
Patient Outcome(s) Other;
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