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

Catalog Number 209063

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 12/21/2017

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

Broken mics handle.There was a surgical delay of 5 minutes.

Manufacturer Narrative

Reported event it was reported that the handpiece had a broken handle.Product history review device history records indicate (b)(4) devices were manufactured under lot k08ln and (b)(4) including (b)(4) were accepted into final stock on 12/06/16.A review of (b)(4) revealed that the issue is not related to the failure alleged in this compliant.Complaint history review a review of complaints related to parts in lot number k08ln, p/n 209063 shows 1 other complaint(s) related to the failure in this investigation.Complaint investigation(s): (b)(4).Visual inspection visual inspection revealed no physical damage of unit.The observation of broken handle was not seen.Dimensional inspection dimensional inspection was not completed.Reported problem was a functional issue.Material analysis material analysis was not completed because the failure was functional.Functional inspection the handpiece was tested in the handpiece test ((b)(4)) and failed.The motor did not spin during the test.Screenshot is attached.Conclusion the handpiece driver electronics (commutation board) communicate with the handpiece trigger.A failure of this communication will break the process that allows the trigger command to result in the motor spinning.Nc/capa history review a review of stryker¿s nc/capa database indicated that (b)(4) are associated with the failure mode reported in this event.

Event Description

Broken mics handle.There was a surgical delay of 5 minutes.

• 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: 7176729
• MDR Text Key: 96846387
• Report Number: 3005985723-2018-00023
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: 4201236 / 42021016
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization