MAUDE Adverse Event Report: MAKO SURGICAL CORP. J6 ARM FOR HIP WITH QD; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207557

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 11/27/2017

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

Could not pass saw blade verification after distal and posterior chamfer cuts.Went to re-register the robot and robot would not pass registration.Changed out the mics, new base array and x-array and new visadics and still would not pass.Then received a j5 error.Tka case delayed for approximately 20 minutes.Case was finished manually.Logs provided are located in the complaints folder:logs_(b)(6) hospital - dr.(b)(6) (b)(6) 2017.Zip.

Manufacturer Narrative

"reported event: could not pass saw blade verification after distal and posterior chamfer cuts.Went to re-register the robot and robot would not pass registration.Changed out the mics, new base array and x-array and new visadics and still would not pass.Then received a j5 error.Device evaluation and results: per gsp 158610:j6 motor cable had internal damage at the end of the bend radius under the new style jevin bracket.This caused the j6 brake to intermittently get energized.The intermittent open on the j6 brake cable triggered the multiple index errors on j5 and j6.I replaced the j6 assembly 207557 with qty (b)(4): 207557 j6 assembly lot: 20755722 with passing results.Product history review a review of device history records shows that on (b)(6) 2009 1 device was inspected and 1 device was placed on: (b)(4).A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 207557, (b)(4) shows no additional complaints related to the failure in this investigation.Conclusions: no errors on either j5 or j6 were noticed during any of the post testing.System passed all posttests and is ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.".

Event Description

Could not pass saw blade verification after distal and posterior chamfer cuts.Went to re-register the robot and robot would not pass registration.Changed out the mics, new base array and x-array and new visadics and still would not pass.Then received a j5 error.Tka case delayed for approximately 20 minutes.Case was finished manually.Logs provided are located in the complaints folder: (b)(6).

• Brand Name: J6 ARM FOR HIP WITH QD
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7074225
• MDR Text Key: 94198015
• Report Number: 3005985723-2017-00592
• 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: 02/21/2018

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: 207557
• Device Lot Number: ROB077
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization