MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209999
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
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
Surgeon expressed that the previous medical done on the patients left side on (b)(6) was difficult and there seemed to be something wrong with the registration.After looking into the case which was on the robot still, it was clear that although it was stated to be a left leg on the robot it was actually the right side was segmented and was used for the left leg operation.Therefore actually the right lateral scan was used for the left medial operation.The right lateral segmented bone was used to cut the left medial bone.Therefore cutting and positioning of the implant likely not ideal.
Event or Problem Description
Surgeon expressed that the previous medical done on the patients left side on the (b)(6) was difficult and there seemed to be something wrong with the registration.After looking into the case which was on the robot still, it was clear that although it was stated to be a left leg on the robot it was actually the right side was segmented and was used for the left leg operation.Therefore actually the right lateral scan was used for the left medial operation.The right lateral segmented bone was used to cut the left medial bone.Therefore cutting and positioning of the implant likely not ideal.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation.An event regarding planning a pka with the wrong op-side scan involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.A review of the dhr associated with rio 479 found quality inspection procedures successfully passed.Based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding planning the wrong op-side for pka.There were no other reported event for the listed catalog number.It was confirmed by review of the scans provided by the mps that the mps selected the incorrect op-side ct scans to plan the case.The mps planned the left side pka case with the right side ct scans.The partial knee user guide (pn 206388 rev03) was reviewed for guidance on ct scan selection.Guidance can be found on page 32.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7635442
• Report Number: 3005985723-2018-00384
• Device Sequence Number: 11151775
• Product Code: OLO
• UDI-Device Identifier: 00848486000578
• UDI-Public: 00848486000578
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170584
• 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): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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: Other