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

Catalog Number	111758
Medical Device Problem Codes	No Device Output (1435); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
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.Pending investigation.
Event or Problem Description
Anspach was not working when ee trigger was pressed.Switched anspach for a new one and it still did not work.After troubleshooting steps completed, discovered the end effector was not working.Not able to complete the procedure robotically.Any surgical delay? surgical delay of less than 15 min.Was procedure completed manually? yes, when anspach and ee failed to work the case was completed manually.Case type: pka.Update: per the mps, she is not sure if the magnet was missing from the end effector.
Event or Problem Description
Anspach was not working when ee trigger was pressed.Switched anspach for a new one and it still did not work.After troubleshooting steps completed, discovered the end effector was not working.Not able to complete the procedure robotically.Any surgical delay, surgical delay of less than 15 min.Was procedure completed manually? yes, when anspach and ee failed to work the case was completed manually.Case type: (b)(4).Per the mps, she is not sure if the magnet was missing from the end effector.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Product identification: the reported device was confirmed to be a makoplasty® partial knee end effector p/n 111758, lot 19460615, s/n (b)(6).Inspection: functional inspection shows the ee was able to turn over the motor up to 80000 rpm and spin it down by releasing the trigger.Product history: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 02/25/2016 with no reported discrepancies.Complaint history review: review of complaints within the trackwise database for p/n 111758, l/n 19460615, s/n (b)(6), show (3) other complaints related to the reported failure.The pr's are 1276702, 1568388, and 1715648.Nc/capa history review: a review of stryker¿s nc/capa database indicated there have been zero ncs or capas associated with the product and failure mode reported in this event.Conclusion: functional inspection shows the ee was able to turn over the motor up to 80000 rpm and spin it down by releasing the trigger.Complaint could not be confirmed.

• 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: 7846013
• Report Number: 3005985723-2018-00522
• Device Sequence Number: 11074926
• Product Code: OLO
• UDI-Device Identifier: 00848486017354
• UDI-Public: 00848486017354
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 19460615 / 1900968
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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