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

Model Number	REF 303-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 it was reported that patient knocked tracheostomy with mitts in situ, which led to tracheostomy inner cannula snapped into three parts.The white ring became detached and there was a fragment left in situ.Clamps had to be used to retrieve the remaining inner cannula body from within the tracheotomy tube to ensure it didn't migrate into the trachea.No health effect on the patient.
Additional Manufacturer Narrative
According to the complaint description the patient knocked tracheostomy with mitts insitu and tracheostomy inner cannula snapped into three parts the white ring became detached and there was a fragment left in situ.A photo/sample was requested but not received up to date.Therefore, a theoretical investigation was conducted.Tracing of the lot number related to the complaint revealed no recurrences of the same issue within the batch; incoming goods inspection and production data are inconspicuous.No clear results available based on the lack of furhter details and photos of the defect tube or the return of the affected tube.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST 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: 24276090
• Report Number: 8010485-2026-63629
• Device Sequence Number: 8569392
• Product Code: JOH
• UDI-Device Identifier: 04035324034314
• UDI-Public: 4035324034314
• 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: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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 303-07
• Device Catalogue Number: REF 303-07
• Device Lot Number: 1100053522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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