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

Model Number	HFD100 - ORT100/200/300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process and further details are being sought from the user regarding this report.Imris is attempting to arrange return of the hfd100 device subject of this report for further analysis; travel to the customer site is currently restricted due to covid.
Event or Problem Description
A customer reported that the female and male skull clamp components of their hfd100 device appear to exhibit slight movement in relation to each other after being fixed with the locking mechanism.The customer also reported this movement could impact their litt cases.No adverse patient consequences or procedural outcomes have been reported in connection with this information.Further information and access to the specific hfd100 device and components is being sought from the customer to investigate the concern.
Additional Manufacturer Narrative
The male and female skull clamp halves, which are components of the hfd100 head fixation device, were returned to the manufacturer and investigated.No device deficiencies related to excess movement play between the skull clamp halves were found during investigation.The unit was free from damage or defects and exhibited no missing hardware or ratcheting teeth where they connect.The base locking knob which locks the two clamp halves together was functionally tested and met requirements.Once pinning load is applied the two halves lock together to form a rigid connection and the user complaint likely stemmed from assembly steps without load applied.Overall the returned device met specification and no patient or procedural impact was reported by the end user.During evaluation, the head of one of six screws on the rocker arm locking knob was observed to be missing.This incidental finding did not impact rocker arm function and is unrelated to the complaint issue of movement between the skull clamp halves.Device serial number was confirmed and included in this followup report.

• Brand Name: IMRIS HFD100 SKULL CLAMP ASSEMBLY
• Common Device Name: SKULL CLAMP
• 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: 14402887
• Report Number: 3010326005-2022-00006
• Device Sequence Number: 5451436
• Product Code: HBL
• UDI-Device Identifier: 00857534006608
• UDI-Public: (01)00857534006608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: HFD100 - ORT100/200/300
• Device Catalogue Number: 119695-000
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2017
• 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
• Patient Sex: Unknown