MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXTIC DEVICE, ROBOTIC

Catalog Number 209999

Device Problems Application Program Problem (2880); Incorrect Device Or Component Shipped (2962)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

A surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, representative noticed a discrepancy in patient name of segmentation plan, the case proceeded manually.The outcome of the case was successful.

Manufacturer Narrative

Reported event: an event regarding incorrect session file involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: not performed as the device being inspected is software.Complaint history: conclusion: nc# (b)(4) has been initiated in order to look into this event.

Event Description

A surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, representative noticed a discrepancy in patient name of segmentation plan, the case proceeded manually.The outcome of the case was successful.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXTIC DEVICE, ROBOTIC
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5916484
• MDR Text Key: 53552270
• Report Number: 3005985723-2016-00272
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Device Lot Number: ROB274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 46 YR
• Patient Weight: 90