MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO FOOT SWITCH; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207138

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 04/25/2017

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

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.The mako education and training manager reported the following: today we had three cases planned at (b)(6) (surgeon dr.(b)(6)).Case 1: hanpice missing magnets and therefore footpedal had to be used.This is reported in a separate pr: (b)(4).Second case was also successful using pka instrument set b.For the third case we had to wait for the pka instrument set a to come out from sterilisation (sterilisation turn over time is almost 3.5 hrs).And when ready we proceeded with the case and all was due to plan until we reached bone preparation where we could verify the bone array and the base array but could not resect bone as the motor was not running.After doing the required trouble shooting to isolate and identify the source of error it was found that the foot pedal was not functioning properly and as this set had already a missing magnet handpiece we had to wait 2.5-3 hrs for the pka set b to be sterilized so that we can use set b handpiece and finish our case.During the time waiting, the patient stayed under anesthesia.

Manufacturer Narrative

Reported event: rio foot switch was not functioning properly.Method & results: device evaluation and results: device evaluation was performed and the rio foot switch event was confirmed.Device history review: not performed as the rio foot switch is an oem product.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding rio foot switch was not functioning properly failure of p/n: 207138, lot #: 303924.There have been no other similar events for the referenced lot number.Conclusions: the rio foot switch is an oem device.Upon receipt, the rio foot switch was bench evaluated by (b)(4) (engineer, r&d robotics) and the reported event was confirmed.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

Event Description

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.The mako education and training manager reported the following: today we had three cases planned at (b)(6) hospital (surgeon dr.(b)(6)).Case 1: handpiece missing magnets and therefore footpedal had to be used.This is reported in a separate pr: (b)(4).Second case was also successful using pka instrument set b.For the third case we had to wait for the pka instrument set a to come out from sterilisation (sterilisation turn over time is almost 3.5 hrs).And when ready we proceeded with the case and all was due to plan until we reached bone preparation where we could verify the bone array and the base array but could not resect bone as the motor was not running.After doing the required trouble shooting to isolate and identify the source of error it was found that the foot pedal was not functioning properly and as this set had already a missing magnet handpiece we had to wait 2.5-3 hrs for the pka set b to be sterilized so that we can use set b handpiece and finish our case.During the time waiting, the patient stayed under anesthesia.

• Brand Name: RIO FOOT SWITCH
• 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: 6530924
• MDR Text Key: 74080798
• Report Number: 3005985723-2017-00198
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K112507
• 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: 06/27/2017

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: 207138
• Device Lot Number: 303924
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• 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