MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS HFD100 HEAD FIXATION DEVICE; 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	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that a torque screw in use with an hfd100 head fixation device broke apart during pinning as pressure was being applied.The customer reported no injury to the patient occurred.A second torque screw was then used in the hfd100 device, after which the surgical procedure proceeded as planned.
Additional Manufacturer Narrative
The torque screw component of the hfd100 device is anticipated to return for analysis and the manufacturer is attempting to collect further detail regarding the event.A follow-up mdr will be submitted after device evaluation and investigation is complete.
Additional Manufacturer Narrative
Further detailed information to support failure mode identification and root cause analysis was requested but not provided in multiple follow-up communications with the customer.Efforts were made to secure additional information and device return over the phone, in person, and over email with clinical and or/mr staff.Confirmation of the failure mode and cause of failure are not possible due to lack of information, and no device return or photos to date.Internal records were reviewed and support the device met specifications prior to the reported event.The manufacturer does not anticipate return of the component reported to break.If further reportable information becomes available a supplemental report will be filed.

• 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: 14569826
• Report Number: 3010326005-2022-00008
• Device Sequence Number: 14996706
• Product Code: HBL
• UDI-Device Identifier: 00857534006592
• UDI-Public: (01)00857534006592
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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 - ORT400 IMPERIAL
• Device Catalogue Number: 119629-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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