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

Catalog Number 209063

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

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

Event Date 07/20/2017

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

Whilst using the mako mics handle for a mako tka case, a screw came loose and fell out of the mako handle dislodging the trigger that allows the angle of the handle to change.The screw was unsterile as was the trigger piece that came off.The item was tagged and sent to cssd.I advised this could not be used until fixed or replaced.The handle angle cannot be changed without this trigger and therefore a case cannot be completed.I offered to get a sterile one for the surgeon who advised it would be fine for the final cut.The handle was in the correct angle for that cut.The trigger and screw fell off during sawing of the last femoral cut.

Manufacturer Narrative

Reported event: it was reported that the pivot locking mechanism broke.Issue was noticed during case, therefor there was no case delay and no patient harm.Device history review: review of device history records indicate 50 devices were manufactured under lot k07sp and 27 including 4200773 were accepted into final stock on 7/29/16.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 k07sp, p/n 209063 shows no other complaint related to the failure in this investigation.Material inspection: material analysis was not completed because functional inspection clearly showed failure.Visual inspection: visual inspection shows the handpiece locking ring screw is backing out of the locking ring.Dimensional inspection dimensional inspection was not completed visual and functional inspection clearly shows the failure of the device.Functional inspection: functional inspection shows the handle is not able to rotate when in the unlocked state.Conclusions: the pivot handle moves the locking ring inside of the rear pivot housing.The handle is not able to rotate if material interferes with the motion of these components.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

Whilst using the mako mics handle for a mako tka case, a screw came loose and fell out of the mako handle dislodging the trigger that allows the angle of the handle to change.The screw was unsterile as was the trigger piece that came off.The item was tagged and sent to cssd.I advised this could not be used until fixed or replaced.The handle angle cannot be changed without this trigger and therefore a case cannot be completed.I offered to get a sterile one for the surgeon who advised it would be fine for the final cut.The handle was in the correct angle for that cut.The trigger and screw fell off during sawing of the last femoral cut.

• 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: 6732426
• MDR Text Key: 80808461
• Report Number: 3005985723-2017-00329
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• 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
• Date Manufacturer Received: 11/29/2017
• 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