MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111758
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
After the surgeon burred out part of the posterior tibia and proceeded to pull the end effector out to burr another portion of the tibia, we saw that the burr came out of the end effector.After taking apart the whole construct and changing out the burr, we realized that the top magnetic clamp of the end effector did not engage correctly, causing the burr to become loose.The end effector was changed out and no damage was done to the patient.Pka case delayed =15 minutes.
Event or Problem Description
After the surgeon burred out part of the posterior tibia and proceeded to pull the end effector out to burr another portion of the tibia, we saw that the burr came out of the end effector.After taking apart the whole construct and changing out the burr, we realized that the top magnetic clamp of the end effector did not engage correctly, causing the burr to become loose.The end effector was changed out and no damage was done to the patient.Pka case delayed =15 minutes.
Additional Manufacturer Narrative
Reported event: the event reported that a partial knee end effector was unable to hold a burr in place during resection.A < or = 15min delay occurred to change device to another.A magnetic component was reported.Device evaluation and results: visual inspection showed normal wear and tear.No components were missing.Functional inspection showed no issue.The collet nuts used during the case were not sent back so a full functional test could not be done.The collet nuts is what helps to hold the hd long and burr in place.Other collet nuts were tested and assembled to the device with no issue.Assembly to hd long and burr worked as expected.Device history review: review of device history records indicate 26 devices were accepted into final stock on 10/31/2014 with no reported discrepancies.Complaint history review: review of complaints for p/n 111758, l/n 26071113 within the trackwise database show no other related complaints.Conclusion: the failure was not confirmed.No issues were found.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.

• Brand Name: MAKOPLASTY® PARTIAL KNEE END EFFECTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7565336
• Report Number: 3005985723-2018-00330
• Device Sequence Number: 11432443
• Product Code: OLO
• UDI-Device Identifier: 00848486017354
• UDI-Public: 00848486017354
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 07/17/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 111758
• Device Lot Number: 2600584
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/17/2018
• 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