MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209830

Device Problem Contamination (1120)

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

Event Date 02/08/2018

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

Biofilm build up discovered inside the offset reamers and in line offset impactors.Tha procedure delayed more than 5 minutes.

Event Description

Biofilm build up discovered inside the offset reamers and in line offset impactors.Tha procedure delayed more than 5 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.The event reported that 4 offset reamer handles and 4 trident inline-offset impactors had biofilm build up.The procedure was delayed 5 minutes.Device evaluation and results: visual inspection showed no irregularities or damage.No foreign matter (biofilm) or debris was seen.Functional inspection showed that the device rotated freely and smoothly.It also inserted into a hip end effector with no issue.Review of the device history records indicate 26 devices were manufactured and accepted into final stock on 11/01/2016.No non-conformances were identified during inspection.Review of complaints within the trackwise database for p/n 209830, l/n 33850 show no other complaints related to the failure in this investigation.The failure was not confirmed.Biofilm was not seen within the device.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7315968
• MDR Text Key: 101709684
• Report Number: 3005985723-2018-00129
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209830
• Device Lot Number: 33850
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization