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 08/22/2017

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

Mako mics hand piece started making loud noise and shuddering during reaming phase of mako tha.Loud noise and shuddering noted mid way through reaming.Reaming completed using manual reamer and hip completed with minimal delay.

Manufacturer Narrative

Reported event: it was reported that the handpiece did not work.Issue was noticed during case, therefor there was less then 15 minutes case delay and no patient harm.Device history review: review of device history records indicate (b)(4) devices were manufactured under lot k07gk and (b)(4) including (b)(4) were accepted into final stock on 6/14/16.Complaint history review: a review of complaints related to parts in lot number k07gk, p/n 209063 shows no other complaint(s) related to the failure in this investigation.Material inspection: material analysis was not completed because the error was functional.Visual inspection: visual inspection revealed no physical damage of unit.Dimensional inspection: dimensional inspection was not completed.Reported problem was a functional issue.Functional inspection: the handpiece was tested in the handpiece test (qip0243) and failed.The motor did not spin during the test.Screenshot is attached.Conclusions: 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that (b)(4) and capa (b)(4) are associated with the failure mode reported in this event.

Event Description

Mako mics hand piece started making loud noise and shuddering during reaming phase of mako tha.Loud noise and shuddering noted mid way through reaming.Reaming completed using manual reamer and hip completed with minimal delay.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6824800
• MDR Text Key: 83891710
• Report Number: 3005985723-2017-00399
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 107