MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS HFD200 HEAD FIXATION DEVICE

Model Number	HFD200
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hfd200 extension assembly containing the remainder of the broken screw is anticipated to return to the manufacturer for analysis.The customer was notified of the finding and had not previously observed the broken screw head or reported issues potentially related to the skull pin socket.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
During routine preventive maintenance, an imris service engineer observed a broken screw head on a component of the hfd200 device.The subject screw connects to a skull pin socket and the hfd200's extension assembly.It is unknown when the screw head broke; there was no patient involved when the issue was found.
Additional Manufacturer Narrative
No device component was returned for analysis.The device had been in use for approximately eight years prior to the observation of a broken screw during planned maintenance.Internal records reviewed confirmed no previous device functional issues or related complaints or internal non-conformances.Communication with the customer confirmed no device functional issues prior to the planned maintenance observation, and a replacement flex arm component was sent to the customer.The probable cause is undetermined at this time.It is possible the device was inadvertently impacted or dropped though this is not confirmable.

• Brand Name: IMRIS HFD200 HEAD FIXATION DEVICE
• Common Device Name: HEAD FIXATION DEVICE
• 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: 13744197
• Report Number: 3010326005-2022-00004
• Device Sequence Number: 19949741
• Product Code: HBL
• UDI-Device Identifier: 00857534006028
• UDI-Public: 00857534006028
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K113748
• 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): 02/09/2022

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: HFD200
• Device Catalogue Number: 113010-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2013
• 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