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

MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Back to Search Results

Model Number 209063

Device Problems Loss of Power (1475); Electrical Power Problem (2925); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

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

Manufacturer Narrative

Intraop op rio set up & registered the robot (identified that mics connection was successful.Upon entering bone cuts, no power to mics.Attempted to reset cutter & wait 10seconds with no avail.Exit page & re-entered with no avail.Disconnected & reconnected the mics with no avail.Did mics status check & failed with no power.Shutdown robot on module & rehomed as well as arm status reboot, then mics status again with no avail.Changed mics.Attempted mics status check & failed.Contacted team mates & fse, proceed to then complete a hard shutdown waiting 2mins robot, attempted mics status check & failed.Surgeon proceeded to manual right tka utilizing as much information attained for bone resection amounts from ligament balancing.Surgeon informed patient case was not completed robotically.Product inspection: as per service maxwo-02133974 & case number (b)(4).Mics-209063, sn#: (b)(6), lot#42040517, rma#282213.Inspected per d06917 and determined failure of the following test step.Sec# 7.1.3.Failed pivot lock handle test.Disposition: rtv.Inspected by: (b)(4).The alleged failure was not confirmed.Device history review: review of the device history records indicate (b)(4) devices were manufactured under lot k09q7 and (b)(4) 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 8 additional complaints related to the failure in this investigation.Conclusion the alleged failure was not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Manufacturer Narrative

When this decision was accessed it was done so through a different criteria.Upon further investigation the conclusion, per our risk documentation, has been updated and the below is the no report rationale.We have revaluated the reportability of this event and have established that this reported hazardous situation has not resulted in any patient harms associated with an s3,03 or higher.A review of the for total knee arthroplasty mako system a0017400.For system experiences unrecoverable malfunction indicates that the highest potential severity of harm is s2 with a potential occurrence level o3.Additionally, a review of the complaint history data for the past 4 years indicated there have been no reports of serious injury or death as a result of similar events with this device family.Based upon this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event is not reportable.

Event Description

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

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

8955795

MDR Text Key

156346367

Report Number

3005985723-2019-00638

Device Sequence Number

Product Code

OLO

UDI-Device Identifier

00848486030193

UDI-Public

00848486030193

Combination Product (y/n)

PMA/PMN Number

K142530

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

company representative

Type of Report

Initial,Followup,Followup

Report Date

04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

09/03/2019

Is this an Adverse Event Report?

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Model Number

209063

Device Catalogue Number

209063

Device Lot Number

LOT: 42051116 SN: 4201429

Was Device Available for Evaluation?

Date Manufacturer Received

04/14/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Hospitalization;

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

Links on this page:

Links on this page: