MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 11/22/2019

Event Type  Injury  

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

Patient reported that she had a right tka done on (b)(6) 2019 and experienced severe electrical burn due to the robotic arm used.Patient stated the 2 days after the surgery she started to get big blisters on her leg.A week after the surgery she was in the emergency room due to the blisters.Patient was sent to the wound care clinic for approx a month.Patient started to experience pain in (b)(6) 2020.The patient went to see her surgeon 3 weeks ago and was told to get an mri.Patient is mainly looking for the catalog, serial and lot of the robotic arm.

Manufacturer Narrative

Reported event: an event regarding an electrical burns involving a mako robotic arm was reported.The event was not confirmed because the patient session files and crisis logs were not available for inspection.There were also no medical records provided to confirm electrical burns and an fse was not requested to inspect the status of the robot.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.Further to this no reported hardware issue has been highlighted from the hospital to stryker.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob615 was inspected on (b)(6) 2017 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob615 shows 0 similar complaints for robotic arm - issue unclear.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data and a review of the robot conducted by either a hospital appointed technician or field service engineer are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text: device not available.

Event Description

Patient reported that she had a right tka done on (b)(6) 2019 and experienced severe electrical burn due to the robotic arm used.Patient stated the 2 days after the surgery she started to get big blisters on her leg.A week after the surgery she was in the emergency room due to the blisters.Patient was sent to the wound care clinic for approx a month.Patient started to experience pain in (b)(6) 2020.The patient went to see her surgeon 3 weeks ago and was told to get an mri.Patient is mainly looking for the catalog, serial and lot of the robotic arm.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11497456
• MDR Text Key: 240170479
• Report Number: 3005985723-2021-00046
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention