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

Catalog Number 209999

Device Problems Electrical /Electronic Property Problem (1198); Device Difficult to Setup or Prepare (1487)

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

Event Date 07/03/2019

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

Case number: (b)(4), mps (b)(6) reported hybrid cable loose and difficulty getting fisso arm to tighten.Update: "problem noticed: loose cables were noticed intra-op prior to making cuts when there was a software error that came up.Case type: pka.Surgical delay: 20 minutes.Update: was the patient under anesthesia? as per mps: "yes the patient was under anesthesia".Case cancelled: no.Case completed successfully: yes.Case completed manually: no, i was able to re-tighten cables as well as troubleshoot the software issue that the system was giving me.We were able to complete the case robotically.Investigation results: yes.

Manufacturer Narrative

Mps reported hybrid cable loose and difficulty getting fisso arm to tighten.Device evaluation and results: per (b)(4): fse replaced part number 201130 artic arms;5800-50 steri, 560mm, m10/m12.System was found to be within mako tolerances and specifications.Product history review: a review of device history records shows that on 04/06/2010 1 device was inspected and no data device was placed on: npr 09-11-0078, npr 10-03-0012, npr 10-03-0032, npr 10-02-0126, npr 10-02-0125, npr 10-02-0097, dev 10-03-0010, dev 10-03-0046, npr 10-03-0157, npr 10-04-0011, npr 10-03-0146, npr 10-03-0056, npr 10-03-0061, npr 10-03-0016, npr 10-03-0057.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 201130 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.

Event Description

Case number: (b)(4), mps (b)(6) reported hybrid cable loose and difficulty getting fisso arm to tighten.Update: "problem noticed- loose cables were noticed intra-op prior to making cuts when there was a software error that came up.Case type: pka.Surgical delay- 20 minutes.Update: was the patient under anesthesia? as per mps: "yes the patient was under anesthesia".Case cancelled- no.Case completed successfully - yes.Case completed manually- no, i was able to re-tighten.Cables as well as troubleshoot the software issue that the system was giving me.We were able to complete the case robotically.Investigation results- yes".

• 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: 8795406
• MDR Text Key: 155873631
• Report Number: 3005985723-2019-00515
• 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: 11/27/2019

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: 07/03/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization