MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS HFD200 HEAD FIXATION DEVICE

Model Number HFD200

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

The hfd200 extension assembly containing the remainder of the broken screw is anticipated to return to the manufacturer for analysis.The customer was notified of the finding and had not previously observed the broken screw head or reported issues potentially related to the skull pin socket.A follow-up report will be submitted upon completion of the investigation.

Event Description

During routine preventive maintenance, an imris service engineer observed a broken screw head on a component of the hfd200 device.The subject screw connects to a skull pin socket and the hfd200's extension assembly.It is unknown when the screw head broke; there was no patient involved when the issue was found.

Manufacturer Narrative

No device component was returned for analysis.The device had been in use for approximately eight years prior to the observation of a broken screw during planned maintenance.Internal records reviewed confirmed no previous device functional issues or related complaints or internal non-conformances.Communication with the customer confirmed no device functional issues prior to the planned maintenance observation, and a replacement flex arm component was sent to the customer.The probable cause is undetermined at this time.It is possible the device was inadvertently impacted or dropped though this is not confirmable.

• Brand Name: IMRIS HFD200 HEAD FIXATION DEVICE
• Type of Device: 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: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13744197
• MDR Text Key: 289470617
• Report Number: 3010326005-2022-00004
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 00857534006028
• UDI-Public: 00857534006028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HFD200
• Device Catalogue Number: 113010-000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2013
• 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