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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.
 
Manufacturer Narrative
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.Product evaluation and results: the reported device was reported/confirmed to be a burr guard assembly.P/n 204992, lot/sn 40m028790.Visual inspection confirms that brr guard to shows material damage from heat friction.See attached images.Product history review: review of the device history records indicate 22 devices were manufactured under lot 40m028790 and accepted into final stock on 03/13/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints related to p/n 204992, lot 40m028790 shows one additional complaint(s) related to the failure in this investigation.Conclusions: the event was confirmed upon visual inspection from the returned product.
 
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 Name
BURR GUARD ASSEMBLY
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8485712
MDR Text Key141382509
Report Number3005985723-2019-00281
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486021856
UDI-Public00848486021856
Combination Product (y/n)N
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/26/2019
Initial Date FDA Received04/04/2019
Supplement Dates Manufacturer Received11/13/2019
Supplement Dates FDA Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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