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

Catalog Number 209999

Device Problems Computer Software Problem (1112); Failure to Calibrate (2440)

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

Event Date 02/13/2019

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

(b)(4) - unable to pass rio registration & j6 locking up.Case type: tka; case was completed manually.Surgical delay: approximately 30 min.Problem: initially mps (b)(4) reported that she could not get the mics (multiple mics) to pass rio registration although the system would pass pre-surgery without issue.While working with the system further she experienced index encoder errors and eventually the arm locked up.

Event Description

(b)(4) - reported by (b)(6)- unable to pass rio registration & j6 locking up.Case type: tka; case was completed manually.Surgical delay: approximately 30 min.Problem: initially mps (b)(6) reported that she could not get the mics (multiple mics) to pass rio registration although the system would pass pre-surgery without issue.While working with the system further she experienced index encoder errors and eventually the arm locked up.

Manufacturer Narrative

Reported event: unable to pass rio registration & j6 locking up.Device evaluation and results: per (b)(4): the arm locked repeatedly during troubleshooting.I tried swapping backside cpci cards and the problem persisted on j6.I cleaned the glass encoder and the problem persisted.I took special measures to clean not only the glass but the encoder as well and that seemed to alleviate the problem.I had difficulty in getting my micro-e tool to operate correctly so i could not check encoder position.I did tighten the screws on the encoder and encoder bracket as well as extensively clean the glass.I also adjusted tensioin on j6 per service manual.Eventually, everything seemed to work correctly.To ensure full and complete operation i did complete a full kinematic calibration as well as j2 bump stop re-calibration and adjustment also did homing constants and wrapped it all up with a full successful has test.Notified mps and hospital staff of my results.Product history review: a review of the dhr associated with (b)(4) found quality inspection procedures successfully passed.Complaint history review : a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(4) shows no additional complaints related to the failure in this investigation.Conclusions: system 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.

• 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: 8413469
• MDR Text Key: 138575394
• Report Number: 3005985723-2019-00219
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization