MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. HFD100 IMPERIAL TORQUE SCREW; HEAD HOLDER (SKULL CLAMP)

Model Number 111236-000

Device Problem Insufficient Information (3190)

Patient Problem Skull Fracture (2077)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

The hfd100 skull clamp assy imperial torque screw in question was returned for evaluation.The torque screw was found to be in calibration when received from the customer.The torque screw was placed in the force gauge measurement fixture and tightened to the 60 lb.Pressure indication line.The force gauge measured 60.2 lbs.Based on our investigation, the torque screw is functioning within original specification and operated as intended.Since there was no device malfunction, there is a possibility that user error caused or contributed to the event, either by not properly evaluating the locations of the pins on the patient's skull, not pinning the patient correctly, or setting the torque screw pressure too high.Data is not available from the hospital to assess the specific application of the skull clamp to this patient.

Event Description

On (b)(6) 2016, a (b)(6) male patient underwent a craniotomy for tumor resection.Near the end of the 10-hour procedure, the surgeon noted a depression in the patient's skull.A ct was performed on the patient, which showed fractures on both right and left sides of the skull where the pins had been placed.The surgeon was concerned that the torque pressure gage (originally set to 60 lbs.) may have been inaccurate.This unit is frequently used and there had been no problems with it prior to this incident.According to the hospital's risk management team, the patient is doing well and is neurologically intact.

• Brand Name: HFD100 IMPERIAL TORQUE SCREW
• Type of Device: HEAD HOLDER (SKULL CLAMP)
• Manufacturer (Section D): IMRIS-DEERFIELD IMAGING, INC.; 5101 s. shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS-DEERFIELD IMAGING, INC.; 5101 s. shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: todd sperling ; 5101 s. shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 5864939
• MDR Text Key: 51737391
• Report Number: 3003807210-2016-00004
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 111236-000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 27 YR
• Patient Weight: 76