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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209954
Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2018
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
Upon entering bone prep, the mics hand piece worked fine when pressing the trigger to align the arm into the haptic field.After releasing the trigger and attempting to cut, there was no power to the mics.After various troubleshooting steps of resetting the cutter, unplug/replug, restarting arm software, there was still no power.When we performed a mics status check, we received an error stating low bus voltage fault.We tried two other mics's and a full system shut down, but nothing always received the same status and could not cut.Upon communicating with the mako hotline, i was informed that the issue was with an internal component and there was nothing that could be done.The procedure was completed using traditional manual instrumentation.Tka case delayed 10 minutes.
 
Event Description
Upon entering bone prep, the mics hand piece worked fine when pressing the trigger to align the arm into the haptic field.After releasing the trigger and attempting to cut, there was no power to the mics.After various troubleshooting steps of resetting the cutter, unplug/replug, restarting arm software, there was still no power.When we performed a mics status check, we received an error stating low bus voltage fault.We tried two other mics's and a full system shut down, but nothing always received the same status and could not cut.Upon communicating with the mako hotline, i was informed that the issue was with an internal component and there was nothing that could be done.The procedure was completed using traditional manual instrumentation.Tka case delayed 10 minutes.
 
Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: mps reported voltage error with the mics.Device evaluation and results: per gsp 164906: replaced commutaion assembly(209954).Tested mics #4203569,4203550,4201609 and 4200617 with passing final test results.Performed all pre-surgery testing with passing final results.Product history review: a review of device history records shows that on 11/04/16 1 device was inspected and 1 device was placed on: qt 16-10-0025, qt 16-10-0013, qt 16-10-0012.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209954, shows 4 additional complaints related to the failure in this investigation.These complaints are: (b)(4).Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
 
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Brand Name
CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key7447593
MDR Text Key106261071
Report Number3005985723-2018-00254
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K170581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/24/2018
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 Number209954
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/26/2018
Initial Date FDA Received04/20/2018
Supplement Dates Manufacturer Received05/20/2018
Supplement Dates FDA Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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