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

Model Number	HFD100 - ORT400 IMPERIAL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the torque screw of an hfd100 head fixation device broke as the torque screw was being advanced through the threads of the hfd100.The break was reported to occur immediately upon inserting the torque screw with little pressure being applied.The procedure was completed by using a second available torque screw.No delay or impact to the patient or procedure was reported; the patient was reported to be stable and the procedure was reported to be successful.
Additional Manufacturer Narrative
A follow-up mdr will be submitted after device evaluation and investigation is complete.
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: 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: 20413016
• Report Number: 3010326005-2024-00013
• Device Sequence Number: 12862106
• Product Code: HBL
• UDI-Device Identifier: 00857534006592
• UDI-Public: (01)00857534006592(11)20211103
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/09/2024

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 - ORT400 IMPERIAL
• Device Catalogue Number: 119629-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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: 3 YR
• Patient Sex: Unknown
• Patient Weight: 19 KG