MAUDE Adverse Event Report: FHC, INC WAYPOINT PLANNER

Model Number	66-WP-PL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original planning file was evaluated by the fhc, inc.Some areas of flooding are evident in the ct scan.Merging issues are noticed around the skull (predominantly the outer and inner edges) indicative of a skew in one direction.The amount of misalignment is difficult to judge quantitatively.Based on scans and facts provided by customer development technicians for this case, it is determined that waypoint planner functioned as it was originally designed to.The software did not exhibit a failure or bug as a result of loading and merging the dicom images.The inability of planner to produce a merge that met the satisfaction of the user can be attributed to poor image quality due to scanners at the facility.The surgery was re-planned using waypoint navigator and was completed successfully with no misalignment.
Event or Problem Description
Surgeon reported to fhc's technical supportive representative regarding image registration in waypoint planner (66-wp-pl).The patient was previously installed with bone anchors and had undergone ct and mri scan.The surgeon did not like the image registration with waypoint planner (66-wp-pl) and decided to use a frame for the patient.Three scans were available for review; ct with anchors, mri and ct with anchors and frame.The ct with anchors and ct with anchors and frame merged very well.The ct to mri showed ac and pc to be more than a millimeter off.As a result of this, surgeon decided to reschedule the surgery.There was no evidence that the patient was harmed in anyway by rescheduling the surgery.

• Brand Name: WAYPOINT PLANNER
• Common Device Name: WAYPOINT PLANNER
• Manufacturer (Section D): FHC, INC; 1201 main street; bowdoin ME 04287
• MDR Report Key: 6897451
• Report Number: 3002250546-2017-00005
• Device Sequence Number: 10985513
• Product Code: HAW
• UDI-Device Identifier: 00873263004371
• UDI-Public: 00873263004371
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K092192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 66-WP-PL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other