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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 Overheating of Device (1437); Loss of Power (1475); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2015
Event Type  malfunction  
Event Description
The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.During the case, the burr motor overheated and shutdown.The backup burr motor was also unavailable during the same case.
 
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: event reported anspach motor overheating and shutting off during surgery.There was no harm to patient or user.The reported 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 of p/n 110940 s/n (b)(4).Conclusions: the anspach motor is an oem device.Upon receipt, the device was evaluated per (b)(4) anspach emax 2 plus burr motor and the reported event was confirmed.
 
Event Description
The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.During the case, the burr motor overheated and shutdown.The backup burr motor was also unavailable during the same case.
 
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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 Key4741064
MDR Text Key5823857
Report Number3005985723-2015-00058
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 03/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2015
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 Received03/27/2015
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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