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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2019

Event Type  malfunction  

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

Surgeon proceeded through registration and joint balancing and cut the tibia first as usual.He commented that the tibia cut seemed to have anterior slope instead of posterior slope.He made the femoral cuts and then recut the tibial cut using manual instruments.He stated the femoral cuts looked fine.The surgery ended satisfactorily except that the patient needed a 19 mm insert.Surgeon thought the tibial cut was off; with anterior slope rather than the planned 3 degree posterior slope.Case type: tka.Surgical delay: 5 minutes.

Event Description

Surgeon proceeded through registration and joint balancing and cut the tibia first as usual.He commented that the tibia cut seemed to have anterior slope instead of posterior slope.He made the femoral cuts and then recut the tibial cut using manual instruments.He stated the femoral cuts looked fine.The surgery ended satisfactorily except that the patient needed a 19 mm insert.Surgeon thought the tibial cut was off; with anterior slope rather than the planned 3 degree posterior slope.Case type: tka.Surgical delay: 5 minutes.

Manufacturer Narrative

Update to b2 and d2.Reported event: an event regarding inaccurate resection involving a mako tka software was reported.The event was not confirmed.Method & results: review of the log/session files has not been completed within 90days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the log/session file review has been completed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob112 was inspected on 14/09/2010 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: rob112 shows 0 similar complaints for tka software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 90days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

• 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: 9258436
• MDR Text Key: 180867202
• Report Number: 3005985723-2019-00767
• 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: 01/04/2021

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
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other