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

Catalog Number 209063

Device Problems Vibration (1674); No Apparent Adverse Event (3189)

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

Event Date 04/26/2017

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 total knee arthroplasty procedure using the robotic arm interactive orthopedic system during the distal femur cut.The arm began shaking vigorously causing us to lose power.Error came up on screen "inconsistent angle discrepancy call service".Clinical support called.Reset arm software.Angle accuracy check performed.Both passed.There was a surgical delay of 30 minutes.

Manufacturer Narrative

The description stated the arm was shaking vigorously, service personable said it was caused by loose cables in the arm and since [the arm] repair there was no issues.Therefore this issue was not related to the handpiece."the product was unavailable for inspection as the product was not returned.The failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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." the device was not returned for evaluation.

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system during the distal femur cut.The arm began shaking vigorously causing us to lose power.Error came up on screen "inconsistent angle discrepancy call service".Clinical support called.Reset arm software.Angle accuracy check performed.Both passed.There was a surgical delay of 30 minutes.

• 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: 6530928
• MDR Text Key: 74078650
• Report Number: 3005985723-2017-00197
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization