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

Catalog Number 209999

Device Problem 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

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

The patient experienced a post op spiral fracture along the femoral shaft.External superior condylar shaft region to mid diaphysis.Her mako tka surgery was conducted on (b)(6) with no adverse events.Pre-op scans showed valgus deformity.Intra-op the medial co-lat ligaments still showed looseness even after valgus implant placement.Valgus implant placement was maxed out but within recommended values and lateral release was conducted to better balance the knee.A ts insert was used for max constraint with a cemented ps femur and universal baseplate.Fracture did not occur in surgery.Fracture occurred on (b)(6) when patient was walking to the bathroom.

Manufacturer Narrative

Reported event: an event regarding a crack/fracture involving a 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 212 found quality inspection procedures successfully passed.-complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding crack/fracture.There was only 2 other reported event ((b)(4)).Conclusion: a case investigation was unable to be performed as the session file was not received.Sessions were not provided.

Event Description

The patient experienced a post op spiral fracture along the femoral shaft.External superior condylar shaft region to mid diaphysis.Her mako tka surgery was conducted on sept.27th with no adverse events.Pre-op scans showed valgus deformity.Intra-op the medial co-lat ligaments still showed looseness even after valgus implant placement.Valgus implant placement was maxed out but within recommended values and lateral release was conducted to better balance the knee.A ts insert was used for max constraint with a cemented ps femur and universal baseplate.Fracture did not occur in surgery.Fracture occurred on oct.17 when patient was walking to the bathroom.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 6980892
• MDR Text Key: 90391463
• Report Number: 3005985723-2017-00518
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention