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

Model Number	HFD100
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during an rns placement procedure, the hfd100 head fixation device was unstable and exhibited play, causing the need to re-pin the patient three times until the patient was successfully pinned without play observed in the device.The customer reported no injuries aside from the multiple extra pin sites, and a delay in the procedure of approximately 60 minutes while the patient was under general anesthesia.The problem was observed during pinning prior to first cut.
Additional Manufacturer Narrative
The customer identified two types of linkage assembly components with potentially loose screws and removed the components from service.The components have been in use for approximately 12 years and subject to iterative preventive maintenance inspection, which had not identified previous device functional issues.The manufacturer arranged return of the components for further analysis; a follow-up report shall be submitted with findings once this is complete.
Additional Manufacturer Narrative
Two second link arm assemblies from hfd100 devices manufactured in 2012 returned to the manufacturer for analysis.Both assemblies had passed recent planned maintenance inspections by imris service engineers.Both second link arms were found to exhibit loose screws for all three screws securing the face of the starburst adapter to the linkage unit.This was confirmed to allow for excess play or movement in the hfd100 device once assembled.Dhr was reviewed and confirmed the assemblies were manufactured correctly.It is probable that use error in handling or cleaning the linkage assemblies between uses contributed to both units exhibiting the loose screws at the same time.

• 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: 20931431
• Report Number: 3010326005-2024-00014
• Device Sequence Number: 5107927
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: (01)00857534006011
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: Health Professional
• Device Model Number: HFD100
• Device Catalogue Number: 111542-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2012
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 32 KG