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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

As part of the 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

The mcl was cut during the case.Dr.(b)(6) noticed the cut during trialing.Case type: tka.Surgical delay: =15 minutes.Update: "thin bent retractor used on the mcl, cut noticed during trialing, limited damage to the mcl".

Manufacturer Narrative

Reported event: an event regarding inaccurate resection (user error) involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that the mcl was cut during the case.The doctor noticed the cut during trialing.Case type: tka.Surgical delay: =15 minutes.Update: "thin bent retractor used on the mcl, cut noticed during trialling, limited damage to the mcl".Method & results: product evaluation and results: the case files provided (crisis logs and patient session file) were reviewed.Areas of investigation included the implant plan, checkpoints, robot registration, bone registration, boundaries, cutting tool history, and service record.All quality metrics pertaining to robot and bone registration and verification were within specification.A review of the tool excursion during the tibia resection showed that the cutting tool did not exit the bone medially or near the probable attachment location of the mcl during tibia preparation.The haptic boundary profiles are designed to protect soft tissue structures.Soft tissue retraction is not monitored by the mako system.Additional potential sources of soft tissue damage are manual instrumentation or failure to retract soft tissue.The data at this time shows that the mako system operated within specification.No system defect or malfunction is suspected.Product history review: review of the device history records associated with rio 262 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for tka software - inaccurate resection - user error.Conclusions: inaccurate resection was not confirmed through inspection of the provided session files.A review of the tool excursion during the tibia resection showed that the cutting tool did not exit the bone medially or near the probable attachment location of the mcl during tibia preparation.The haptic boundary profiles are designed to protect soft tissue structures.Soft tissue retraction is not monitored by the mako system.Additional potential sources of soft tissue damage are manual instrumentation or failure to retract soft tissue.The data at this time shows that the mako system operated within specification.No system defect or malfunction is suspected.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tka software - inaccurate resection- user error.

Event Description

The mcl was cut during the case.Dr.(b)(6) noticed the cut during trialing.Case type: tka.Surgical delay: =15 minutes update: "thin bent retractor used on the mcl, cut noticed during trialing, limited damage to the mcl".

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8966878
• MDR Text Key: 156660512
• Report Number: 3005985723-2019-00644
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• 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
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 94