MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Output Problem (3005); Complete Loss of Power (4015)

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

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

Both guns died.Case type: tka.Patient was under anesthesia.

Event Description

Both guns died.Case type: tka.Patient was under anesthesia.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Both guns died.Case type: tka.Patient was under anesthesia.Product inspection product was not inspected as the product was not returned for evaluation.Device history review: review of the device history records indicate 25 devices were manufactured under lot k09q7 and 24 devices were accepted into final stock on 06-21-2017.A review of qt17-06-0068 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42040517 shows 3 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusion the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9165868
• MDR Text Key: 165473695
• Report Number: 3005985723-2019-00721
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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: 209063
• Device Lot Number: 42040517 / 4202268
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization