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 316-08
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complaint description the pilot balloon was found to have detached from tracheostomy during use.The defect could be verified at the received sample looking like a sharp cut or bite, as no stretch marks could be seen.Tracing of the lot related to the complaint revealed no recurrences of the same issue within the batch; the incoming good inspection and the production data are inconspicuous.All cuffs and cuff systems of the tracoe tracheostomy cannulas undergo a 100% quality inspection during production, with any leaking or nonperforming products being discarded.Therefore, it is confirmed that the product was originally in perfect condition.However, the defect was detected during use.Therefore, it can be assumed that sharp-edged structures or instruments in the area of the filling line near the pilot ballon led unintended to the defect during use.Nevertheless, the cause cannot be conclusively determined but seems outside manufacturer's control.
Event or Problem Description
On (b)(6) 2026 pilot balloon detachment on the tracheostomy was reported.Emergency tube change was required.

• 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: 24518711
• Report Number: 8010485-2026-66203
• Device Sequence Number: 13175593
• Product Code: JOH
• UDI-Device Identifier: 04035324019083
• UDI-Public: 4035324019083
• 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): 03/05/2026

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 316-08
• Device Catalogue Number: REF 316-08
• Device Lot Number: 1100050061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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