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 08/29/2017

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

Two mics handpieces failed mics status check and we were unable to use them.There was a surgical delay of 10 minutes.Case tka.

Manufacturer Narrative

"reported event: it was reported that the handpiece did not work.Issue was noticed before case, therefor there was a 10 minute case delay and no patient harm.Device history review: review of device history records indicate 25 devices were manufactured under lot k08sh and 25 including 4201314 were accepted into final stock on 01/05/17.No issues were identified during inspection.Complaint history review: a review of complaints related to parts in lot number k08sh, p/n 209063 shows no other complaint related to the failure in this investigation.Visual inspection: visual inspection revealed no physical damage of unit.Dimensional inspection: dimensional inspection was not completed functional inspection clearly shows the failure of the device.Functional inspection: upon receiving, mics worked intermittently when cable was exercised, turning on properly when trigger was pulled and off when cable was moved.Shortly after, mics stopped working.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: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Two mics handpieces failed mics status check and we were unable to use them.There was a surgical delay of 10 minutes.Case tka.

• 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: 6884633
• MDR Text Key: 89245591
• Report Number: 3005985723-2017-00448
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170581
• 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: 12/01/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 12/01/2017
• 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