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

Model Number	HFD100
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The torque screw and skull clamp table adapter were returned for evaluation.The torque screw was found to be functioning within specifications.The table adapter was found to be seized and full clamping could not be achieved.The adapter was unable to be disassembled for further inspection, but the seizing was most likely caused by internal deformation in the internal part, potentially by application of excess force or cross-threading.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.
Event or Problem Description
During a patient procedure on (b)(6) 2019, two neurosurgeons noticed the loose fit of the hfd100 skull clamp assembly.The patient's head moved during drilling however, the patient did not sustain any injuries other than skin damage.

• Brand Name: IMRIS HFD100
• 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: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13441555
• Report Number: 3010326005-2019-00041
• Device Sequence Number: 16665054
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 00857534006011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 02/20/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2016
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 17 KG