MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM; STEROTAXIC DEVICE

Catalog Number 204000

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

The surgeon performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Towards the end of the case, the rio arm experienced joint motor errors.The resulting outcome of the case was successful and there was no harm to patient.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.A mako field service engineer conducted on-site testing of the rio and was able to confirm the alleged failure of the robotic arm.The issue was resolved.A supplemental report will be filed if additional information is obtained in the future.

Manufacturer Narrative

Reported event: the reported device was confirmed to be a j5 top assembly, p/n 200422, lot rob056.Device evaluation and results: according to gsp case (b)(4), the j5 motor returned from the field with hall errors.Device history review: review of the device history records indicate 1 robot arm that included the reported j5 top assembly was manufactured and accepted into final stock on 05/06/2009.Complaint history review: a review of complaints related to p/n 200422 on rob056 shows no other complaints related to the failure in this investigation.Tracking of complaints related to the 200422 part number will be tracked through quarterly trend request #767.Conclusions: the failure was confirmed during the inspection.

Event Description

The surgeon performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Towards the end of the case, the rio arm experienced joint motor errors.The resulting outcome of the case was successful and there was no harm to patient.

• Brand Name: 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM
• Type of Device: STEROTAXIC DEVICE
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 4760145
• MDR Text Key: 5948080
• Report Number: 3005985723-2015-00070
• Device Sequence Number: 1
• Product Code: OLO
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention