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

Model Number	HFD100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imris engineer was on-site at the facility to assess the head fixation device and linkages, with no performance or mechanical issues noted.The removable torque screw component involved in the event was removed from the skull clamp and returned to the manufacturing site for evaluation.A follow-up report will be submitted once the investigation into this event is complete.
Event or Problem Description
It was reported the frame of the hfd100 slipped while a patient's head was pinned.The patient was in the prone position with 60 lbs of pressure exerted by the torque screw, and all joints were reported to have been checked by two people during pinning and confirmed to be tight.The slippage occurred prior to entering sterile field; there was no negative impact or consequence to the patient or procedure reported.
Additional Manufacturer Narrative
No performance or mechanical issues in the device were found during on-site investigation by an imris engineer at the facility.No discrepancies or anomalies were observed in the returned torque screw component.Preventive maintenance records for the site were reviewed and no discrepancies with respect to the head fixation device or associated linkages were identified.There is a possibility unintended user error related to pinning technique caused or contributed to the event, however this cannot be conclusively determined.

• Brand Name: IMRIS HFD100 HEAD FIXATION DEVICE
• 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: 12644511
• Report Number: 3010326005-2021-00013
• Device Sequence Number: 4233172
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: (01)00857534006011
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/17/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 93 KG