MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS HFD200 RADIOLUCENT HFD; HEAD FIXATION DEVICE,

Model Number	HFD200
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, a patient underwent a cervical procedure using intraoperative computed tomography (ict) with image guidance.The patient was positioned in the prone position and the torque on the drive knob was set at 60ibs.The hfd200 was connected to linkage on the table and the patient's body was padded appropriately.During transfer and initial connection to linkage of hfd200, the surgical staff did not notice change in head position, movement of the rocker arm, or force applied to the fixation frame.The procedure was successful and afterwards, sutures and gauze was placed on the patient's cervical prone area where the incision was performed.The hfd200 was disconnected and the patient was rolled from the prone position to supine to stop anesthesia.After removing the patient from the hfd200, a 5cm laceration was observed behind the patient's ear on the side where the rocker arm was positioned.The operating room staff tested the rocker arm after the surgery and it functioned as intended.The laceration required sutures to close.
Additional Manufacturer Narrative
The hfd200 skull clamp assembly underwent visual inspection and load testing.A discrepancy was observed in the drive knob force gauge.The force applied was not accurately displayed on the gauge.The drive knob was disassembled to investigate the root cause.The plunger insert inside the drive knob was found to be broken.It is undeterminable how the plunger insert broke - whether it was customer misuse of the drive knob (applying excessive force) or fatigue of the material.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.

• Brand Name: IMRIS HFD200 RADIOLUCENT HFD
• 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: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13425764
• Report Number: 3010326005-2018-00036
• Device Sequence Number: 4034247
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Recall
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0163-2020
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 100 KG