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

Model Number	REF 311-07
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a very rare error for the tracoe twist plus cannula which was only reported once in 2024.One causal factor can be seen in strong mechanical stress during application, the use of unsuitable cleaning agents or disinfectants, which led to tensile or shear forces in the material.No information is available of the duration of use of this cannula, which may also have an influence of the stability of the cannula's components.A further cause might be the material or the manufacture of the ring itselfe.
Event or Problem Description
1) what went wrong? pin(s) of the ring break during inner tube change.Shaft of tracheostomy cannula became disconnected from attachment ring on flange.Shaft could slip out of patient stoma.2) description of health effects.No health effects reported, but patient required urgent tracheostomy change.Therefore the patient was distressed due to discomfort.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST PLUS TRACHEOSTOMY 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: 20479450
• Report Number: 8010485-2024-00036
• Device Sequence Number: 12830970
• Product Code: JOH
• UDI-Device Identifier: 04035324017942
• UDI-Public: 4035324017942
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K893866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: REF 311-07
• Device Catalogue Number: REF 311-07
• Device Lot Number: 1100018113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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: Other
• Patient Sex: Unknown