MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SHAVER BLADE 4MM - STR 0 DEG 5PK

Catalog Number	TSB4STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trudi shaver blade - 0 degree (tsb4str) jaw feature, broke off during use in a functional endoscopic sinus surgery (fess).While shaving the ethmoid sinuses, the jaw feature that rotates reportedly popped off into the patient's sinus during shaving dissection.The part was removed.It was reported that the origo (device used with the trudi shaver blade) was working as normal; nothing was noticeably wrong and no abnormalities in the sinuses were noted.It took ten (10) minutes for staff to retrieve device pieces and open a new device.It was reported that no patient injury or death occurred.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional b5 narrative: it was subsequently reported that the blade had been clogged during the procedure.A device history record (dhr) review was performed and no non-conformances or manufacturing irregularities were identified related to this failure.A return kit was issued and the trudi shaver blade - 0 degree (tsb4str) was reportedly shipped to bien air, as they are responsible for the device evaluations.To date, no results have been made available.This complaint will be reopened and updated upon receipt of investigation report from bien air and supplemental report will be submitted, as applicable.

• Brand Name: TRUDI SHAVER BLADE 4MM - STR 0 DEG 5PK
• Common Device Name: TRUDI SHAVER BLADE
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; 31 technology drive; CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine; CA 92618
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23025654
• Report Number: 3003418325-2025-00054
• Device Sequence Number: 15878459
• Product Code: PGW
• UDI-Device Identifier: 10705031469235
• UDI-Public: 10705031469235
• Combination Product (Y/N): N
• PMA/510(K) Number: K221037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Catalogue Number: TSB4STR
• Device Lot Number: 250708A-PC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORIGO.
• Patient Sex: Unknown