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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2017
Event Type  Injury  
Manufacturer Narrative
Follow-up #1 and final report submitted to update sections catalog #, based on the results of investigation. During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured. The tka was aborted. The product was unavailable for inspection as the product was not returned. Unable to perform as the lot number was not provided. Unable to perform as the lot number was not provided. Product was unavailable for inspection and lot information unavailable for device history review. User manual identifies predrilling of hard bone may be required and sites publications which support the potential for risk of fracture near the bone pin sites. Based on users experience, this failure mode is a knowledge based error. A review of stryker¿s nc/capa database indicated there have been 0 ncs and capas associated with the product and failure mode reported in this event. Device not returned.
 
Event Description
During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured. The tka was aborted.
 
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
During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured. The tka was aborted.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key6957813
MDR Text Key295984654
Report Number3005985723-2017-00505
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/18/2017 Patient Sequence Number: 1
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