MAUDE Adverse Event Report: MAKO SURGICAL CORP. EE DOUBLE ANGLE COLLET; STEREOTAXIC DEVICE, ROBOTICS

Model Number	111748
Medical Device Problem Codes	Computer Software Problem (1112); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
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
The burr did not engage when the surgeon pressed the trigger on the anspach.I reset the cutter and no power to the anspach.I reset the arm software and no power to the anspach.I changed the anspach and ran a burr status check with the trigger and the foot pedal and failed both.I did a hard shut down, re-homed the robot, did another burr status check.I fail both the trigger and foot pedal.I finally swapped out the end effector and ran another burr status check, homed the robot and passed the burr status check.We successfully completed the case.Case type: pka; surgical delay: 20-30 minutes.
Event or Problem Description
The burr did not engage when the surgeon pressed the trigger on the anspach.I reset the cutter and no power to the anspach.I reset the arm software and no power to the anspach.I changed the anspach and ran a burr status check with the trigger and the foot pedal and failed both.I did a hard shut down, re-homed the robot, did another burr status check.I fail both the trigger and foot pedal.I finally swapped out the end effector and ran another burr status check, homed the robot and passed the burr status check.We successfully completed the case.Case type: pka.Surgical delay: 20-30 minutes.
Additional Manufacturer Narrative
Based on the information provided there is no indication or allegation that device reported in this investigation may have contributed to the event and is therefore considered concomitant.Per the event description: "as reported: "the burr did not engage when the surgeon pressed the trigger on the anspach.I reset the cutter and no power to the anspach.I reset the arm software and no power to the anspach.I changed the anspach and ran a burr status check with the trigger and the foot pedal and failed both.I did a hard shut down, re-homed the robot, did another burr status check.I fail both the trigger and foot pedal.I finally swapped out the end effector and ran another burr status check, homed the robot and passed the burr status check.We successfully completed the case.".

• Brand Name: EE DOUBLE ANGLE COLLET
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8724594
• Report Number: 3005985723-2019-00449
• Device Sequence Number: 1685288
• Product Code: OLO
• UDI-Device Identifier: 00848486002565
• UDI-Public: 00848486002565
• 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): 01/27/2020

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 Model Number: 111748
• Device Catalogue Number: 111748
• Device Lot Number: 19140217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 12/29/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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