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

Model Number	HFD100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The skull clamp assembly and torque screw involved in the reported event were returned, inspected, and functionally tested.No discrepancies were observed with respect to function, component condition, or components present.The male and female halves of the skull clamp assembly were found to be free of damage and free of excess play or movement.The skull clamp assembly base locking knob and rocker arm (two-pin) locking knob were assessed and confirmed to be functioning as intended to lock and prevent movement of the rocker arm or skull clamp halves.No discrepancies were found in the indicated pressure output of the returned torque screw used in conjunction with the skull clamp assembly.Pinning or fixation technique is the most likely cause of the slippage based on information available; a supplemental report will be submitted if any additional reportable information is received.
Event or Problem Description
A customer reported that on (b)(6) 2023, we were doing a craniotomy for a tumor resection, and while using the hfd (pins) on a patient, our patient's head slipped in the pins.The initial pressure was 50lbs, and when the slip occurred, during surgery, while drilling out the bone flap, we checked and it had slipped to 20lbs.The patient was 120kg, so not sure if that could have been a factor.We switched the mayfield and pins out under the drapes.Further information gathered from the customer reported that positioning this patient was difficult due to size of the patient and achieving the correct amount of flexion for the head was not easy.The patient was re-pinned underneath the drapes using a backup head fixation device.The customer reported they were not able to do the imri scan and are unsure if patient moved much during slippage and that is why the patient didn't fit in the scanner.It was reported the case was completed and the patient experienced a small laceration at a pin site on the scalp that required a suture at the end of the case, and that the patient likely got a routine post-op scan.No further injury or impact was reported.

• 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: 16401647
• Report Number: 3010326005-2023-00002
• Device Sequence Number: 5138399
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 120 KG