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 04/04/2017

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

Mics died during 1st cut (distal femoral) and could not get it to fire again after resetting cutter, changing page in plan, restarting arm software, full reboot, and swapping mics multiple times.Bailed to manual tka.Session files in complaints.Swapping out mics per fse¿s request.Was there a surgical delay? if so, how long? 10 minutes.Robot surgery not completed; switched to manual tka.Field service visit - (b)(6).During repair found: pn 209954 lot 20995405-2 rob123 mics communication problems.Pn 209954 lot 507954-2 rob123 mics hand piece does not activate.During a tka case, mics stopped during a cut and could not be started again after swapping the mics and full shutdown.Reported by (b)(6).Per (b)(6), the three mics handpieces were used during the tka case and none of them worked.When the fse tested them, he confirmed that only one mics handpiece was not working and the other two were fine.(b)(6) confirmed that he only returned the one mics handpiece that the fse confirmed did not work.

Manufacturer Narrative

"reported event: it was reported that handpiece did not work.Issue was noticed during case, therefore there was a 10 minute case delay and no patient harm.Device history review: review of device history records indicate (b)(4) devices were manufactured under lot k089x and (b)(4) including 4201030 were accepted into final stock on 12/16/2016.Complaint history review: a review of complaints related to parts in lot number k089x, p/n 209063 shows 1 other complaint(s) related to the failure in this investigation.The complaint investigations are: 1484673".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 ((b)(4)) and failed.The motor did not spin during the test.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

Mics died during 1st cut (distal femoral) and could not get it to fire again after resetting cutter, changing page in plan, restarting arm software, full reboot, and swapping mics multiple times.Bailed to manual tka.Session files in complaints.Swapping out mics per fse¿s request.Was there a surgical delay? if so, how long? 10 minutes.Robot surgery not completed; switched to manual tka.Field service visit - (b)(4).During repair found: pn 209954 lot 20995405-2 rob123 mics communication problems.Pn 209954 lot 507954-2 rob123 mics hand piece does not activate.During a tka case, mics stopped during a cut and could not be started again after swapping the mics and full shutdown.Reported by mps (b)(4).Update: per (b)(4), the three mics handpieces were used during the tka case and none of them worked.When the fse tested them, he confirmed that only one mics handpiece was not working and the other two were fine.(b)(4) confirmed that he only returned the one mics handpiece that the fse confirmed did not work.

• 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6569034
• MDR Text Key: 75316019
• Report Number: 3005985723-2017-00220
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

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: 4201030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: No
• 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