MAUDE Adverse Event Report: MAKO SURGICAL CORP. CAMERA, POLARIS SPECTRA; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207335

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

As part of 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

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system.The mako procedure was canceled and converted to manual.While registering the femur, the registration points on the lateral femur kept showing up anywhere from 1.5mm to 3.0 mm deep.Re-registered the femur 4 times before a passable registration was obtained.As the last verification bubble was popped, the screen greyed out like it does when it can no longer see any arrays.A camera connection error then popped up on the screen.

Manufacturer Narrative

Reported event: camera - polaris spectra "ndi camera with the error light flashing".Method & results: -device evaluation and results: device evaluation was performed at the customer site and the camera - polaris spectra event was confirmed.-device history review: not performed as the camera - polaris spectra is an oem product.-complaint history review: based on the device identification the complaint databases were reviewed from 2011 to present for similar reported events regarding the camera - polaris spectra failed ndi accuracy checks.There have been 3 other events for the referenced part number.(b)(4).Conclusions: the camera - polaris spectra is an oem device.Per gsp case (b)(4), successfully replaced the ndi camera with the error light flashing.The camera - polaris spectra is an oem device and was returned to the supplier for rework / repair.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.Trend request #813 has been initiated to continue to monitor for events related to this device.

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system.The mako procedure was canceled and converted to manual.While registering the femur, the registration points on the lateral femur kept showing up anywhere from 1.5mm to 3.0 mm deep.Re-registered the femur 4 times before a passable registration was obtained.As the last verification bubble was popped, the screen greyed out like it does when it can no longer see any arrays.A camera connection error then popped up on the screen.

• Brand Name: CAMERA, POLARIS SPECTRA
• Type of Device: STEREOTAXIC 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6460279
• MDR Text Key: 71743039
• Report Number: 3005985723-2017-00165
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

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 Number: 207335
• Device Lot Number: P7-03286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• 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 Number: 1
• Patient Outcome(s): Hospitalization