MAUDE Adverse Event Report: STRYKER CORP./ MAKO SURGICAL CORP. MAKO ROBOTIC ARM

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2016

Event Type  Injury  

Event Description

Mako robot by stryker ortho failed.The sensors stopped communicating with the computer.This happened after beginning a surgery for a knee replacement.The hospital had to call in another company to use their instruments and implants instead of the mako/stryker which could not be fixed after 15 minutes of failed attempts in the operating room.

• Brand Name: MAKO ROBOTIC ARM
• Type of Device: MAKO ROBOTIC ARM
• Manufacturer (Section D): STRYKER CORP./ MAKO SURGICAL CORP.
• MDR Report Key: 5784876
• MDR Text Key: 49410558
• Report Number: MW5063331
• Device Sequence Number: 1
• Product Code: HSX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention