MAUDE Adverse Event Report: HOLLISTER, INC. ANCHORFAST; ORAL ENDOTRACHEAL TUBE FASTENER

Model Number	9700
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	11/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not saved; therefore, a sample evaluation could not take place.Lot number was not provided, so a dhr was unable to be performed.Only the di of the udi information is known due to lack of lot number information.Hollister will continue to monitor for this issue.
Event or Problem Description
(b)(6) in (b)(6) canada reported an incident involving one of their patient's that had a hollister securement device endotracheal tube anchorfast with biteguard.It was reported that the device was positioned in the middle when the patient bit down and reportedly broke three of their bottom incisors.

• Brand Name: ANCHORFAST
• Common Device Name: ORAL ENDOTRACHEAL TUBE FASTENER
• Manufacturer (Section D): HOLLISTER, INC.; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER, INC.; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville, IL 60048
• MDR Report Key: 23863024
• Report Number: 1119193-2025-00045
• Device Sequence Number: 9409177
• Product Code: CBH
• UDI-Device Identifier: 00610075095810
• UDI-Public: 00610075095810
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: 9700
• Device Catalogue Number: 9700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown