MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS HFD200 RADIOLUCENT HFD; HEAD FIXATION DEVICE

Model Number HFD200

Device Problems Break (1069); Misassembly by Users (3133); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

Preliminary investigation found that excess force may have been used during reassembly of the device, causing the threaded drive rod component to break.A follow-up report will be submitted once the investigation is complete.

Event Description

It was reported that during reassembly after cleaning, the threaded drive rod of the hfd200 head fixation device broke.At the time the drive rod broke, a hospital staff member was demonstrating how to reassemble the device and may have over-torqued the drive rod during reassembly.No patient was involved.

Manufacturer Narrative

The threaded drive rod component of the hfd200 device was returned and the issue was confirmed.An imris service engineer went on-site and discussed the component breakage with the user facility staff, who stated the breakage occurred during handling as the device was being reassembled after cleaning.The staff reported they overtightened the component during reassembly.The returned component did not show evidence of a material defect, and the component supplier confirmed no related raw material or manufacturing nonconformances.

• Brand Name: IMRIS HFD200 RADIOLUCENT HFD
• Type of Device: HEAD FIXATION DEVICE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13467511
• MDR Text Key: 296235257
• Report Number: 3010326005-2022-00002
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 00857534006028
• UDI-Public: 00857534006028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HFD200
• Device Catalogue Number: 113010-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1