MAUDE Adverse Event Report: MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO; STEREOTAXIC DEVICE

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

The surgeon was performing a makoplasty total knee arthroplasty using the robotic arm interactive orthopedic system (rio) and the kinetis cr total knee implant system as part of an ide study ((b)(4)).On a post-operative x-ray, the surgeon noticed that a bone pin tip broke off during insertion into the tibia.The surgeon decided to leave the bone pin tip implanted.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been conducted at mako surgical.The available pin was not retained for the investigation.It was discarded at the end of the case.The remainder of the pin could not be removed from the patient because the broken piece of the pin was below the surface of the bone.The failure in this complaint is attributed to patient hard bone and the user not following recommended technique by redirecting the pin off-axis upon insertion.This mdr is being filed because of the bone pin breakage and because the bone pin is also currently available for use in the same manner as with the rio for partial knee arthroplasty under k112507.

• Brand Name: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
• Type of Device: STEREOTAXIC DEVICE
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 3941119
• MDR Text Key: 4575098
• Report Number: 3005985723-2014-00046
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KINETIS CR TOTAL KNEE IMPLANT SYSTEM