MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA

Model Number	REF 521-09-X
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defect was verified at one of the received samples which shows an inner plastic "ring" or web which reduces the lumen.The further received inner canulas from the same lot don't show a restriction of the lumen.This is a rare injection molding defect caused by the two mold parts not closing completely during the injection molding process.We have not received any other complaints regarding this type of defect.The product was produced in (b)(6) 2024.The respective inner cannula lots are derived from old tools which are not in use any more at the supplier.
Event or Problem Description
During routine bronchoscopy it was not possible to insert the bronchoscope.The lumen of the inner cannula shows a lumen restriction of approx.50%, presumably due to a manufacturing defect in the inner cannula.The use of the inner cannula could lead to a potentially life-threatening situation.We have secured both the inner cannula and the packaging unit.No patient harm reported.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA
• Common Device Name: TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA
• 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: 24648272
• Report Number: 8010485-2026-67384
• Device Sequence Number: 13201694
• Product Code: JOH
• UDI-Device Identifier: 04035324018253
• UDI-Public: 4035324018253
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/20/2026

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 521-09-X
• Device Catalogue Number: REF 521-09-X
• Device Lot Number: 1100038174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• 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: Male