MAUDE Adverse Event Report: SPIRAIR, INC SEPTALIGN; DELIVERY DEVICE - EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL

Model Number	FG-0032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hardened steel trocar tip was bent at mid-section.Expected physiologic conditions would not be expected to apply this much force to the trocar tip.Please note that this is the company's first emdr submission and was unavoidably delayed due to the sign-up process.
Event or Problem Description
During delivery of the implant, it was noted that a portion of the delivery device tip had broken off into the cartilage.The piece was easily retrieved prior to completion of the procedure.There was no adverse effect.

• Brand Name: SEPTALIGN
• Common Device Name: DELIVERY DEVICE - EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL
• Manufacturer (Section D): SPIRAIR, INC; 415 grand avenue; suite 201; south san francisco CA 94080
• Manufacturer (Section G): SPIRAIR, INC; 415 grand avenue; suite 201; south san francisco CA 94080
• Manufacturer Contact: tracey henry ; 415 grand avenue; suite 201; south san francisco, CA 94080 ; 6504686176
• MDR Report Key: 21256330
• Report Number: 3030653921-2024-00001
• Device Sequence Number: 9178946
• Product Code: NHB
• UDI-Device Identifier: 00860011696308
• UDI-Public: 01008600116963081725062310101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Expiration Date: 06/23/2025
• Device Model Number: FG-0032
• Device Catalogue Number: SPLN001
• Device Lot Number: 1012172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male