Mako Surgical

Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

The bearings of the saw attachments were ungreased.

The bearings of the saw attachments were ungreased.

Communication-connection error.

Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

Out of tolerance.

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

Incorrect product and/or label. Sizing is labeled incorrectly.

Software discrepancy of not showing all the EE constants, when the screen is filled.

Software discrepancy of not showing all the EE constants, when the screen is filled.

An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

Failure of the Offset Cup Reamer Handle not engaging its mating components.

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

Potential disassociation of the orientation pin.

Revision of the field manual

Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.

The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

The product may be mislabeled and could result in the incorrect implant being used.

MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.