MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTACTIC DEVICE, INSTRUMENT

Catalog Number 111758

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

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

Event Date 01/19/2016

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

A surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.During the case, the mako end effector malfunctioned and the end effector would not engage once entering haptics.Trouble shooting was performed by mps.The robotic arm was still functional and manual override was performed on the software.The problem still persisted and the surgeon finished burring the post holes, the outcome of the case was successful and there was no harm to the patient.

Manufacturer Narrative

Reported event: the event reported that a partial knee end effector would not engage when in haptics.Device evaluation and results: -visual inspection: no irregularities or damage.-dimensional inspection: alleged failure not related to dimensional properties.-functional inspection: burr status check was repeated three times with a rio 3.0 system and working anspach motor.The end effector successfully functioned as designed for all runs.The failure was not confirmed.Device history review: review of device history records indicate (b)(4) devices were accepted into final stock on 08/04/2015 with no reported discrepancies.Complaint history review: a review of complaints related to p/n 111758, l/n 19180315 shows no complaints related to the failure in this investigation.Tracking of complaints related to p/n 111758 will be tracked through quarterly trend request #740.Conclusions: the failure was not confirmed.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

A surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.During the case, the mako end effector malfunctioned and the end effector would not engage once entering haptics.Trouble shooting was performed by mps.The robotic arm was still functional and manual override was performed on the software.The problem still persisted and the surgeon finished burring the post holes, the outcome of the case was successful and there was no harm to the patient.

• Brand Name: MAKOPLASTY® PARTIAL KNEE END EFFECTOR
• Type of Device: STEREOTACTIC DEVICE, INSTRUMENT
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5383472
• MDR Text Key: 36534890
• Report Number: 3005985723-2016-00038
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/19/2016

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: 111758
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• 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): Other