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

Model Number	HFD200
Medical Device Problem Codes	Break (1069); Misassembly by Users (3133); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3010326005-2022-00002
• Device Sequence Number: 14625294
• Product Code: HBL
• UDI-Device Identifier: 00857534006028
• UDI-Public: 00857534006028
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K113748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: HFD200
• Device Catalogue Number: 113010-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/06/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown