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

Model Number	HFD100
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During routine imris preventive maintenace on an hfd100 head fixation device, the service engineer observed approximately 3mm of movement after the rocker arm locking knob on one of the skull clamp halves was locked into place.There was no patient involvement in this finding, and the assembly was tagged and removed from ongoing use by customer site staff.
Additional Manufacturer Narrative
Manufacturer is arranging for return of the skull clamp assembly for further evaluation.A follow up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The skull clamp assembly was returned to the manufacturer for further evaluation.The issue was identified during routine preventive maintenance intended to detect excess play or unintended component movement.The ability to rotate the rocker arm was confirmed in the returned device and further traced to a loose rocker arm locker / screw inside the assembly.The device had passed prior preventive maintenance inspections and no reports of unintended device movement had been received from the customer; there was no patient or procedural involvement.No manufacturing anomalies were observed in the returned rocker arm component or in a review of manufacturing records.This report also encompasses udi related data quality updates to match brand name and udi with gudid data and correct the parent device serial number.

• 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 (Section G): 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
• MDR Report Key: 20261658
• Report Number: 3010326005-2024-00012
• Device Sequence Number: 8722728
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: (01)00857534006011(11)20170905
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: Other
• Device Model Number: HFD100
• Device Catalogue Number: 113803-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2017
• 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 Sex: Unknown