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

Catalog Number 209063

Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)

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

Event Date 09/23/2019

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

Mics handpiece malfunctioned during a hip replacement procedure.Trigger button was not working when in the haptics for reaming the acetabulum.Trigger work when outside of haptics.Called mps hotline and tried to troubleshoot the issue.They recommended a full shut down and to swap out the handpiece.Surgeon decided to ream manually while waiting for robot to reboot.Robot functioned well after reboot and changing out the mics.Case type: tha, surgical delay: 20 minutes.

Event Description

Mics handpiece malfunctioned during a hip replacement procedure.Trigger button was not working when in the haptics for reaming the acetabulum.Trigger work when outside of haptics.Called mps hotline and tried to troubleshoot the issue.They recommended a full shut down and to swap out the handpiece.Surgeon decided to ream manually while waiting for robot to reboot.Robot functioned well after reboot and changing out the mics.Case type: tha.Surgical delay: 20 minutes.

Manufacturer Narrative

Mics handpiece malfunctioned during a hip replacement procedure.Trigger button was not working when in the haptics for reaming the acetabulum.Trigger work when outside of haptics.Called mps hotline and tried to troubleshoot the issue.They recommended a full shut down and to swap out the handpiece.Surgeon decided to ream manually while waiting for robot to reboot.Robot functioned well after reboot and changing out the mics.Product evaluation and results: mics-209063 sn#(b)(6), lot#42080219, rma#(b)(4).Inspected per (b)(4) and determined failure of the following test step.Sec# 7.1.2.Visual inspection test.Disposition: rtv.Inspected by: (b)(6).Product history review: device history records indicate (b)(4) devices were manufactured under lot k0ch9 and (b)(4) devices were accepted into final stock on 03/27/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, prodex lot k0ch9 shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.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: 9141597
• MDR Text Key: 160847346
• Report Number: 3005985723-2019-00706
• 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: 12/13/2019

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: 209063
• Device Lot Number: 42080219 / 4206132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization