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

Model Number 209999

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)

Patient Problems Damage to Ligament(s) (1952); Tissue Damage (2104)

Event Date 10/17/2019

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

Dr.(b)(6) claims that the patella tendon was slightly cut during the procedure.He states that it was probably because it¿s a tight knee and says that there should be warnings about any knee that¿s not a standard knee.Case type: tka.

Manufacturer Narrative

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 rob069 was inspected on 03/08/2009 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: rob069 shows 3 similar complaints for tka software - inaccurate resection.The complaint record numbers are: (b)(4).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.

Event Description

Doctor claims that the patella tendon was slightly cut during the procedure.He states that it was probably because it¿s a tight knee and says that there should be warnings about any knee that¿s not a standard knee.Case type: tka.

• 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: 9258411
• MDR Text Key: 164888928
• Report Number: 3005985723-2019-00765
• 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?: 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: 10/17/2019
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 92