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

Model Number	MP-KIT-P-BI-00590
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Physician informed fhc that there was an issue with a starfix case.Physician reports that a platform height of 130 was chosen for the plan for this bilateral platform for patient.In the case physician observed a value of t=30 on the platform embossing.Being new to starfix, she followed this label and implanted the lead at 30 without questioning it.In post-operative scans, it was observed that the lead is 10 mm short of her target.The patient impact is that he/she will require a revision which bick plans to do using rosa.Physician informed fhc that they decided to bring the patient back in for a revision on10/1 with the same platform.They re-processed the platform and reattached without issue.Patient did very well during the revision surgery and in post-op.

• Brand Name: FHC WAYPOINT STEREOTACTIC SYSTEM
• Common Device Name: STEREOTACTIC INSTRUMENT
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• MDR Report Key: 10756025
• Report Number: 3002250546-2020-00006
• Device Sequence Number: 19704581
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K092192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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-00590
• Device Catalogue Number: MP-KIT-P-BI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization