MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ WAYPOINT ANCHORS NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 66-WP-AN5

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

Patient was undergoing a deep brain stimulator lead placement. Reportedly, tip of one of the fiducial screws broke off and was left in the patient's skull due to its small size. No patient harm was reported.

• Brand Name: MICROTARGETING¿ WAYPOINT ANCHORS
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC.; 1201 main st.; bowdoin ME 04287
• MDR Report Key: 7167180
• MDR Text Key: 96460609
• Report Number: 7167180
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 66-WP-AN5
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage