MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST PLUS TRACHEOSTOMY CANNULA; TRACOE TWIST PLUS TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE

Model Number	REF 316-07
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sub-glottic port became detached from the body of the tube when patient was being rolled.No pressure or pulling of tube.It required an tube change.
Additional Manufacturer Narrative
According to the complaint description the sub-glottic port became detached from the body of the tube when pt was being rolled.No pressure or pulling of tube.In situ between (b)(6) 2026 - (b)(6) 2026.No lot/photo/sample available to date.The initial claimed twist cannula was stated to be twist plus later on.However, based on the complaint description, the issue is consistent with the known failure pattern concerning subglottic suction line detachment in twist plus during clinical use.This issue was addressed under a related capa000330, implementation is completed.However, due to the missing lot it cannot be determined if the cannula was produced prior to capa implementation.No further sample investigation required, as rca within capa completed with testing of model variant.The failure pattern appears to be multifactorial, with the primary root cause related to design limitation of the subglottic suction and surfaces preparation prior to bonding.Certain clinical conditions, such as inhalation therapy, mechanical stress, microbiological environment, may contribute to adhesive bond failure.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer (Section G): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer Contact: margarete halle ; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 24660964
• Report Number: 8010485-2026-67986
• Device Sequence Number: 18448325
• Product Code: JOH
• UDI-Device Identifier: 04035324019076
• UDI-Public: 4035324019076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K961449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: REF 316-07
• Device Catalogue Number: REF 316-07
• Device Lot Number: N.A.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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