MAUDE Adverse Event Report: FHC, INC, WAYPOINT STEREOTACTIC PLATFORM; WAYPOINT STEREOTACTIC SYSTEM

Model Number	MP-KIT-P-BI
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the platform used in the surgery was returned and evaluated.The investigation shows that no issues were found during receiving, processing, manufacturing and qc'ing of the original platform.The returned platform was inspected and found to have non-conforming measurements that are well over the specified tolerances.This is indicative that the geometry of the platform was altered after leaving fhc.The follow-up case was successful.Since the second platform was processed, manufactured and qc'd just as the original, this lends to the conclusion that the problem with the first platform happened outside of fhc control.A root cause could not be determined at this time.
Event or Problem Description
Physician had difficulty attaching the starfix platform to the implanted fiducials at the start of the case.He checked multiple times the peek standoffs from the sks kits and was still having difficulty attaching the final posterior left foot the standoff.It showed a 3mm posterior shift that physician did not feel comfortable proceeding with the surgery with 3 legs without knowing why the 4th leg was shifted so much.The surgery was cancelled and the impact to the patient was opening the fiducial sites and closing again and having the patient get another ct to double check everything.The case concluded successfully with the use of the platform created from the 2nd set of ct scans.

• Brand Name: WAYPOINT STEREOTACTIC PLATFORM
• Common Device Name: WAYPOINT STEREOTACTIC SYSTEM
• Manufacturer (Section D): FHC, INC,; 1201 main street; bowdoin ME 04287
• MDR Report Key: 8927503
• Report Number: 3002250546-2019-00006
• Device Sequence Number: 19340124
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: MP-KIT-P-BI
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1