MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC SURGICAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Device Fell (4014)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

The mako robot arm's screw loosened, and the arm fell off during the tka (total knee arthroplasty) surgery.The robotic arm with the saw attachment was brought onto the field and the tibial and femoral cuts were made according to plan.Notably the plastic handle of the robotic arm screw came loose between bone cuts and fell to the floor, not contaminating the sterile field, but this handle had to be covered with ioban, a towel and coban before proceeding.Manufacturer response for mako robot, robotic surgical system (per site reporter) the arm was replaced.

• Brand Name: MAKO ROBOTIC SURGICAL SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• MDR Report Key: 15461682
• MDR Text Key: 300323836
• Report Number: 15461682
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 3.100.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Race: White