MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SHAVER BLADE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	TSB4STR
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode is pgw/erl: the device was not returned; therefore, no further investigation can be performed.A manufacturing record evaluation was performed and no non-conformances related to the complaint was found during the review.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
The healthcare professional reported that there was significant inaccuracy on the trudi navigation system during a primary functional endoscopic sinus surgery (fess) in the operating room (or).During initial registration the trudi probe, 0, 5in (tdp0005, 230926a-pc) did not initially recognize the fiducial points, and while tracing the registration probe green lines were no longer appearing green.To troubleshoot, the caller restarted the system, this resolved the registration issue, the probe was working.Then, mid-case the accuracy of the instruments was "significantly off." they tried using a new suction, a new trudi shaver blade - straight, double serrated, 4.0mm x 110mm (tsb4str, 250107f-pc), a new probe, they reregistered, tried using a new disposable patient tracker, all without resolution.The suction device used was greater than 30 uses, out of warranty but this did not explain the other accuracy issues.The case was continued without resolution.There was no allegation that a death or serious injury occurred due to the use of the product.There was no report of the patient requiring medical intervention.Non acclarent devices were used.Additional event information received on 12-apr-2025 indicated that the customer confirmed accuracy in the known landmarks in endoscopic visualization inside the nasal cavity.Inaccuracy was first noticed early into the case and determined proximity to the skull base and middle turb.Accuracy was validated using the suction and probe.Ct image was used as the primary image with more then 300 slides.The field view was axial.There were no noticeable defects to the ct scanned image.The surgeon performed the registration and has performed several of them, this was the first-time accuracy issue for this person.Anatomy was accuracy was confirmed at the medial and lateral canthus.It was noted that it is not sure if there a potential for metal interference, it¿s always a possibility.No ferromagnetic material was placed within the trudi zone.The event was isolated to one patient.The patient tracker nor the patient tracker cable moved under tension in relation to this event.The emitter pad was not moved.No other device¿s shaft was in proximity to an emitter pad¿s transmitter.The serial number of the patient tracker involved is disposable tracker lot # d2620.The information indicated that when the issue with the shaver blade occurred, the icon on the trudi system was green.The crosshairs did not turn ¿yellow¿.The inaccuracy was within 2mm.It was noted that when the issue with the trudi probe, the icon on the trudi system was green.The crosshairs did not turn ¿yellow¿.The inaccuracy was within 2mm.Sterilization was used per the instructions foe use ifu).The icon on the trudi system was orange when using the trudi shaver blade.The crosshairs did not turn ¿yellow¿and the inaccuracy was not within 2mm.

• Brand Name: TRUDI SHAVER BLADE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park building; rio segundo; alajuela 90109 ; CS 90109
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21936636
• Report Number: 3005172759-2025-00031
• Device Sequence Number: 5228980
• Product Code: ERL
• UDI-Device Identifier: 10705031469235
• UDI-Public: (01)10705031469235(11)250107(17)260107(10)250107F-PC
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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 Expiration Date: 01/07/2026
• Device Catalogue Number: TSB4STR
• Device Lot Number: 250107F-PC
• 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: 04/12/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRUDI NAVIGATION SYSTEM
• Patient Sex: Unknown