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)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  malfunction  

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

Measured distal cuts with the green probe which were 2.4 deep on the lateral side, and 3.2 deep on the medial.With the planar probe we were shown to be 1.4 deep, with 3 degrees varus and 3 degrees flexed on the lat side.With the planar probe on the med side we were 2.1 deep, 3.0 varus and 2.7 degrees flexed.Bone prep screen showed no red on the distal cut, excluding osteophytes.Bone registration was.3 for the femur.Probe registration was.9 for the blue and.3 for the green.Robot registration was at.27.When measured with a caliper, lateral condyle that was removed, measured 6mm.Planned resection on the lat side was 1.5 mm.On top of this, we were 2.4 deep according to the green probe, and so out total should have been 3.9 mm.Case completed manually.No surgical delay.Case type / application: tka.

Event Description

Measured distal cuts with the green probe which were 2.4 deep on the lateral side, and 3.2 deep on the medial.With the planar probe we were shown to be 1.4 deep, with 3 degrees varus and 3 degrees flexed on the lat side.With the planar probe on the med side we were 2.1 deep, 3.0 varus and 2.7 degrees flexed.Bone prep screen showed no red on the distal cut, excluding osteophytes.Bone registration was.3 for the femur.Probe registration was.9 for the blue and.3 for the green.Robot registration was at.27.When measured with a caliper, lateral condyle that was removed, measured 6mm.Planned resection on the lat side was 1.5 mm.On top of this, we were 2.4 deep according to the green probe, and so out total should have been 3.9 mm.Case completed manually.No surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving a mako tka software was reported.The event was not confirmed.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided."(b)(6) 2021" was not available in software shared drive.The archive tar.Gz file has not been provided and therefore a review of the logs is not possible.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob100 was inspected and the quality inspection procedures were completed with no reported discrepancies complaint history review: there have been 4 other similar events for the lot referenced.Conclusions: the alleged failure mode was not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.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 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: not available.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12495391
• MDR Text Key: 272188610
• Report Number: 3005985723-2021-00159
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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
• Device Lot Number: ROB100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female