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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BURR GUARD ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. BURR GUARD ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 204992
Device Problems Material Integrity Problem (2978); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2019
Event Type  Malfunction  
Manufacturer Narrative

As part of the 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

During a bilateral mpka 3. 0 case the burr guard became defective. While starting to burr the posterior aspect of the femur; a circular piece of the epoxy lining from the burr guard came out into the patient. When examining the burr guard it looked to be slightly smoking from what we anticipated as heat/ the epoxy getting worked out. I explained to the doctor what this was and where it was coming from along with our options. I also stressed while using this same assembly the importance of thoroughly flushing out the knee. We finished the case with the burr guard and original assembly. For the right knee, a new burr guard and rotary attachment were opened and the same burr was used. There were no issues with this burr guard or assembly on the right leg. Clinically the only difference noted between sides and the issue was when burring the posterior aspect of the lt leg there were slight patches of red from the proximal burr hitting the femur as we burred the most posterior aspect of the femur. The right side we flexed up more and this red was not noticed. Was there any harm to the patient or user: potential for burr guard epoxy remanence being left behind. Case type: pka 3. 0.

 
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Brand NameBURR GUARD ASSEMBLY
Type of DeviceSTEREOTAXIC 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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8485712
MDR Text Key141382509
Report Number3005985723-2019-00281
Device Sequence Number1
Product Code OLO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142530
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 12/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number204992
Device LOT Number40M028790
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/04/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
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: 04/04/2019 Patient Sequence Number: 1
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