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

Catalog Number	204992
Medical Device Problem Codes	Material Integrity Problem (2978); Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: BURR GUARD ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8485712
• Report Number: 3005985723-2019-00281
• Device Sequence Number: 1900053
• Product Code: OLO
• UDI-Device Identifier: 00848486021856
• UDI-Public: 00848486021856
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 204992
• Device Lot Number: 40M028790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization