MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. HEAD FIXATION DEVICE HFD100; SKULL CLAMP

Model Number	HFD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The torque screw component is reaplced as part of standard preventive maintenance.The torque screw at issue had been in use for approximately 4 months as of the event date.The torque screw was taken out of service and returned to the manufacturer by the imris field service engineer.Upon receipt it was confirmed the torque screw exhibited a crack/breakage in the threaded housing that interfaces with the hfd100 skull clamp component.Further investigation of the issue is in process and a follow-up mdr will be submitted after investigation is complete.
Event or Problem Description
A customer reported the torque screw component of the hfd100 head fixation device did not feel secure when pinning the patient.The surgeon continued use of the torque screw and the hfd100 device, and completed the planned procedure with the device.The customer reported no patient injury occurred due to the issue.
Additional Manufacturer Narrative
Investigation confirmed the torque screw component was manufactured within specification, however the mechanical design of the component may contribute to cracking in the threaded housing component of the torque screw.The manufacturer has initiated corrective and preventive action to further address this issue.This report also encompasses udi related data quality updates to match brand name and udi with gudid data.

• Brand Name: HEAD FIXATION DEVICE HFD100
• Common Device Name: SKULL CLAMP
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 21132036
• Report Number: 3010326005-2025-00001
• Device Sequence Number: 20712023
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: (01)00857534006011(11)20160818
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103493
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: HFD100
• Device Catalogue Number: 113803-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 80 KG