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 10/02/2019

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

In a mako tha case, during cup impaction, the initial ¿distance remaining¿ was 8 mm and, after a couple of gentle impactions, went suddenly to -1 mm.While this result can happen some times, in this case the impaction applied by the surgeon could not be sufficient to sit the cup in such a deep position compared to the deepest ream.The base array wasn¿t bumped as verified by the successful end-effector checkpoint.The surgeon didn¿t want to use the acetabular checkpoint in this case, however the pelvic array looked very stable upon check, thus making a bumped pelvic array very unlikely.The surgeon visually inspected the cup and was happy with its position and fixation.The orientation was also checked using the ¿surgical results¿ page, and the results where within the tolerance of the system (2 degrees).However, a planar x-ray done intra-op (after the liner was inserted) showed the cup to be approximately 3 mm proud of the deepest ream (see attached comparison between plan and x-ray).The robot has recently received its regular maintenance, and all registrations and checkpoints checks (pelvis and rio) passed well within tolerance in this case.The approach was direct anterior, using offset handles.The cup was a hemispherical and we reamed 1 mm under the cup size.The surgeon accepted the result and went on with the final joint reduction.

Event Description

In a mako tha case, during cup impaction, the initial ¿distance remaining¿ was 8 mm and, after a couple of gentle impactions, went suddenly to -1 mm.While this result can happen some times, in this case the impaction applied by the surgeon could not be sufficient to sit the cup in such a deep position compared to the deepest ream.The base array wasn¿t bumped as verified by the successful end-effector checkpoint.The surgeon didn¿t want to use the acetabular checkpoint in this case, however the pelvic array looked very stable upon check, thus making a bumped pelvic array very unlikely.The surgeon visually inspected the cup and was happy with its position and fixation.The orientation was also checked using the ¿surgical results¿ page, and the results where within the tolerance of the system (2 degrees).However, a planar x-ray done intra-op (after the liner was inserted) showed the cup to be approximately 3 mm proud of the deepest ream (see attached comparison between plan and x-ray).The robot has recently received its regular maintenance, and all registrations and checkpoints checks (pelvis and rio) passed well within tolerance in this case.The approach was direct anterior, using offset handles.The cup was a hemispherical and we reamed 1 mm under the cup size.The surgeon accepted the result and went on with the final joint reduction.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving a mako tha 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 (b)(6) was inspected on 02/03/2016 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: (b)(6) shows 0 similar complaints for tha 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: 9191243
• MDR Text Key: 167129907
• Report Number: 3005985723-2019-00732
• 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: health professional
• 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: 10/02/2019
• Initial Date FDA Received: 10/15/2019
• 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